An observational study in Classical Hodgkin Lymphoma and Relapsed or Refractory Classical Hodgkin Lymphoma, sponsored by Takeda. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-25.
Sponsored by Takeda · Observational
The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.
This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.
The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:
Group 1: cHL Group 2: RRHL
This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).
Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants diagnosed with high-risk stage IIb-IV cHL and/or with RRHL between 01 January 2010 and 31st December 2013 from the 13 participating countries.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
Group 2, RRHL: Progression Free Survival (PFS)
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by \>=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
Time frame: From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10 percent \[%\] of body weight over 6 months).
Time frame: Day 1 at cHL diagnosis
Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10 % of body weight over 6 months).
Time frame: Day 1 at RRHL diagnosis
Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10% of body weight over 6 months).
Time frame: At second, third, fourth, and fifth relapse (up to 9 years 10 months)
Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category
IPS score was calculated based on following factors: age \>=45 years, male sex, stage IV disease, albumin\<4 gram per liter (g/L), white blood cell (WBC)\>=15\*10\^9 per liter (/L), haemoglobin \<10.5 g/L, and lymphocyte count\<0.6\*10\^6/L or \<8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate.
Time frame: Day 1 at cHL diagnosis
Group 1, cHL: Number of Participants With B Symptoms at Diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of \>=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
Time frame: Day 1 at cHL diagnosis
Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of \>=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
Time frame: Day 1 at RRHL diagnosis
Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment
Number of participants were categorized based on prior therapies for HL at each line of treatment.
Time frame: Day 1 at RRHL diagnosis
Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received
Time frame: Day 1 at RRHL diagnosis
Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens
Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse)
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease
Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible
Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility
Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment
Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other. More than one line of treatment or therapy was selected for each participant.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other.
Time frame: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants
Time frame: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. More than one line of treatment or therapy was selected for each participant
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants
Time frame: From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants
Time frame: From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of PET or CT Scan Assessments
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT
Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other. Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT
Known risk factors for relapse after ASCT included time to first relapse less than or equal to (\<=) 3 months, stage IV disease at relapse, bulky disease \>=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission \[PR\] or PET positivity), performance status (eastern Cooperative oncology group \[ECOG\]) \>=1. The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities).
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens
Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT
Time frame: From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT)
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Median PFS
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. PD was defined as any new lesion or increase by \>= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
Time frame: From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment
Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir.
Time frame: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment
Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir.
Time frame: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Mean Duration of Best Response
Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir.
Time frame: From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Median Overall Survival (OS)
Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact.
Time frame: From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years
Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported. 5 year overall survival data were reported only for participants who had \>5 year observation periods.
Time frame: At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Overall Survival Rate at 1 and 5 Years
Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported. 5 year overall survival data were reported only for participants who had \>5 year observation periods.
Time frame: At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT
Each participant had more than one category presented for salvage therapy and ASCT.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Each participant had more than one category presented for salvage therapy and ASCT.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. Each participant had more than one category presented for salvage therapy and ASCT.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT
Each participant had more than one category presented for salvage therapy and ASCT. Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures.
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT
Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Data abstraction took place in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Russia, Saudi Arabia, South Africa, Province Of China, Turkey, Singapore and Republic of Korea from 21 November 2017 to 31 October 2019. Participants diagnosed with high-risk stage IIb-IV classical Hodgkin lymphoma (cHL) (Group 1) or with relapsed/refractory classical Hodgkin lymphoma (RRHL) (Group 2) between 2010 and 2013 were observed in this study.
| Milestone | Group 1: cHL | Group 2: RRHL |
|---|---|---|
| Started | 1598 | 0 |
| Completed | 1598 | 0 |
| Not completed | 0 | 0 |
| Milestone | Group 1: cHL | Group 2: RRHL |
|---|---|---|
| Started | 0 | 426 |
| Participants were counted in both groups | 0 | 321 |
| Completed | 0 | 426 |
| Not completed | 0 | 0 |
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by \>=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
| months | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Progression Free Survival (PFS) | 13.17 (9.92 to 20.17) |
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10 percent \[%\] of body weight over 6 months).
| Participants | Group 1: cHL |
|---|---|
| Stage I-A | 0 |
| Stage I-B | 0 |
| Stage II-A | 0 |
| Stage II-B | 441 |
| Stage III-A | 207 |
| Stage III-B | 356 |
| Stage IV-A | 161 |
| Stage IV-B | 433 |
| Stage unknown | 0 |
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10 % of body weight over 6 months).
| Participants | Group 2: RRHL |
|---|---|
| Stage I-A | 7 |
| Stage I-B | 2 |
| Stage II-A | 24 |
| Stage II-B | 61 |
| Stage III-A | 52 |
| Stage III-B | 78 |
| Stage IV-A | 53 |
| Stage IV-B | 107 |
| Stage unknown | 42 |
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of \>=10% of body weight over 6 months).
| Participants | Group 2: RRHL |
|---|---|
| Clinical stage at 2nd relapse — Stage I-A | 1 |
| Clinical stage at 2nd relapse — Stage I-B | 0 |
| Clinical stage at 2nd relapse — Stage II-A | 6 |
| Clinical stage at 2nd relapse — Stage II-B | 9 |
| Clinical stage at 2nd relapse — Stage III-A | 9 |
| Clinical stage at 2nd relapse — Stage III-B | 15 |
| Clinical stage at 2nd relapse — Stage IV-A | 9 |
| Clinical stage at 2nd relapse — Stage IV-B | 14 |
| Clinical stage at 2nd relapse — Stage unknown | 16 |
| Clinical stage at 3rd relapse — Stage I-A | 0 |
| Clinical stage at 3rd relapse — Stage I-B | 0 |
| Clinical stage at 3rd relapse — Stage II-A | 2 |
| Clinical stage at 3rd relapse — Stage II-B | 4 |
| Clinical stage at 3rd relapse — Stage III-A | 2 |
| Clinical stage at 3rd relapse — Stage III-B | 4 |
| Clinical stage at 3rd relapse — Stage IV-A | 1 |
| Clinical stage at 3rd relapse — Stage IV-B | 3 |
| Clinical stage at 3rd relapse — Stage unknown | 6 |
| Clinical stage at 4th relapse — Stage I-A | 1 |
| Clinical stage at 4th relapse — Stage I-B | 0 |
| Clinical stage at 4th relapse — Stage II-A | 1 |
| Clinical stage at 4th relapse — Stage II-B | 0 |
| Clinical stage at 4th relapse — Stage III-A | 0 |
| Clinical stage at 4th relapse — Stage III-B | 1 |
| Clinical stage at 4th relapse — Stage IV-A | 1 |
| Clinical stage at 4th relapse — Stage IV-B | 2 |
| Clinical stage at 4th relapse — Stage unknown | 2 |
| Clinical stage at 5th relapse — Stage I-A | 0 |
| Clinical stage at 5th relapse — Stage I-B | 0 |
| Clinical stage at 5th relapse — Stage II-A | 1 |
| Clinical stage at 5th relapse — Stage II-B | 0 |
| Clinical stage at 5th relapse — Stage III-A | 0 |
| Clinical stage at 5th relapse — Stage III-B | 0 |
| Clinical stage at 5th relapse — Stage IV-A | 0 |
| Clinical stage at 5th relapse — Stage IV-B | 0 |
| Clinical stage at 5th relapse — Stage unknown | 1 |
IPS score was calculated based on following factors: age \>=45 years, male sex, stage IV disease, albumin\<4 gram per liter (g/L), white blood cell (WBC)\>=15\*10\^9 per liter (/L), haemoglobin \<10.5 g/L, and lymphocyte count\<0.6\*10\^6/L or \<8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate.
| Participants | Group 1: cHL |
|---|---|
| Good risk (IPS 0-1) | 289 |
| Fair risk (IPS 2-3) | 504 |
| Poor risk (IPS 4-7) | 294 |
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of \>=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
| Participants | Group 1: cHL |
|---|---|
| Presence of B-symptoms | 1230 |
| Absence of B-symptoms | 368 |
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of \>=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
| Participants | Group 2: RRHL |
|---|---|
| Presence of B-symptoms | 248 |
| Absence of B-symptoms | 178 |
Number of participants were categorized based on prior therapies for HL at each line of treatment.
| Participants | Group 2: RRHL |
|---|---|
| Frontline treatment | 425 |
| Second line treatment | 17 |
| Third line treatment | 1 |
| Pre-SCT line treatment | 1 |
| previous treatment regimen | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received | 1.0 (1.0 to 4.0) |
Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other.
| Participants | Group 1: cHL |
|---|---|
| Therapy regimen 1 | 1363 |
| Therapy regimen 3 | 1 |
| Therapy regimen 6 | 2 |
| Therapy regimen 7 | 9 |
| Therapy regimen 8 | 11 |
| Therapy regimen 10 | 3 |
| Therapy regimen 11 | 1 |
| Therapy regimen 17 | 2 |
| Therapy regimen 18 | 1 |
| Therapy regimen 4 | 104 |
| Therapy regimen 14 | 15 |
| Therapy regimen 15 | 4 |
| Therapy regimen 2 | 33 |
| Therapy regimen 24 | 114 |
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other.
| cycles | Group 1: cHL |
|---|---|
| Therapy regimen 1 | 6.0 (6.0 to 6.0) |
| Therapy regimen 3 | 5.0 (5.0 to 5.0) |
| Therapy regimen 6 | 6.0 (6.0 to 6.0) |
| Therapy regimen 7 | 2.0 (1.0 to 4.0) |
| Therapy regimen 8 | 2.0 (2.0 to 6.0) |
| Therapy regimen 10 | 2.0 (2.0 to 2.0) |
| Therapy regimen 11 | 4.0 (4.0 to 4.0) |
| Therapy regimen 17 | 7.0 (6.0 to 8.0) |
| Therapy regimen 18 | 3.0 (3.0 to 3.0) |
| Therapy regimen 4 | 6.0 (1.0 to 8.0) |
| Therapy regimen 14 | 6.0 (1.0 to 8.0) |
| Therapy regimen 15 | 3.5 (1.0 to 7.0) |
| Therapy regimen 2 | 6.0 (4.0 to 11.0) |
| Therapy regimen 24 | 6.0 (1.0 to 9.0) |
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other.
| Participants | Group 1: cHL |
|---|---|
| Therapy regimen 1 | 2 |
| Therapy regimen 6 | 1 |
| Therapy regimen 7 | 8 |
| Therapy regimen 8 | 15 |
| Therapy regimen 10 | 8 |
| Therapy regimen 11 | 6 |
| Therapy regimen 12 | 2 |
| Therapy regimen 13 | 1 |
| Therapy regimen 18 | 2 |
| Therapy regimen 16 | 6 |
| Therapy regimen 4 | 6 |
| Therapy regimen 14 | 2 |
| Therapy regimen 24 | 10 |
| Participants | Group 1: cHL |
|---|---|
| RT Type: Whole body | 10 |
| RT Type: Involved-field | 244 |
| RT Type: Involved-site | 94 |
| RT Type: Involved-node | 60 |
| RT Type: Other | 1 |
| RT Site: Abdominal nodes | 8 |
| RT Site: Axillary nodes | 21 |
| RT Site: Bone lesions | 9 |
| RT Site: Breast | 3 |
| RT Site: Cervix | 3 |
| RT Site: Inguinal nodes | 7 |
| RT Site: Larynx | 1 |
| RT Site: Lung | 5 |
| RT Site: Mediastinal nodes | 197 |
| RT Site: Neck nodes | 69 |
| RT Site: Pancreas | 1 |
| RT Site: Para-aortic nodes | 6 |
| RT Site: Para-iliac nodes | 3 |
| RT Site: Pelvic nodes | 7 |
| RT Site: Skin | 3 |
| RT Site: Soft tissue | 2 |
| RT Site: Spleen | 7 |
| RT Site: Supraclavicular nodes | 14 |
| RT Site: Thyroid | 1 |
| RT Site: Other | 42 |
Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease.
| Participants | Group 1: cHL |
|---|---|
| RT for pre-planned frontline treatment | 225 |
| RT for residual FDG-avid disease | 115 |
| percentage of participants | Group 2: RRHL |
|---|---|
| Eligible for ASCT | 68.7 |
| Ineligible for ASCT | 31.3 |
| Initially ineligible and became eligible for ASCT | 7.6 |
| Became eligible and received ASCT | 60.0 |
| Eligible and received ASCT | 73.5 |
| Eligible and did not receive ASCT | 26.5 |
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other.
| cycles | Group 2: RRHL |
|---|---|
| Therapy regimen 1 | 6.0 (1.0 to 8.0) |
| Therapy regimen 6 | 8.0 (8.0 to 8.0) |
| Therapy regimen 8 | 2.0 (2.0 to 4.0) |
| Therapy regimen 11 | 3.0 (2.0 to 3.0) |
| Therapy regimen 12 | 5.0 (5.0 to 5.0) |
| Therapy regimen 18 | 4.0 (4.0 to 4.0) |
| Therapy regimen 22 | 6.0 (6.0 to 6.0) |
| Therapy regimen 24 | 2.0 (2.0 to 16.0) |
Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown.
| Participants | Group 2: RRHL |
|---|---|
| Participant refusal | 21 |
| Inability to mobilize stem cells | 3 |
| Loss of response to chemotherapy | 13 |
| Cumulative Toxicities | 1 |
| Other | 11 |
| Comorbid conditions | 2 |
| Unknown | 29 |
Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others.
| Participants | Group 2: RRHL |
|---|---|
| Advanced age | 12 |
| Comorbid conditions | 13 |
| Chemo-resistant disease | 19 |
| Cumulative toxicities | 1 |
| Other | 11 |
| Participant refusal | 5 |
| Inability to mobilize stem cells | 1 |
| Loss of response to chemotherapy | 4 |
| Unknown | 55 |
Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other. More than one line of treatment or therapy was selected for each participant.
| Participants | Group 2: RRHL |
|---|---|
| Frontline: Therapy regimen 1 | 161 |
| Frontline: Therapy regimen 3 | 1 |
| Frontline: Therapy regimen 6 | 1 |
| Frontline: Therapy regimen 7 | 4 |
| Frontline: Therapy regimen 11 | 1 |
| Frontline: Therapy regimen 18 | 1 |
| Front line: Therapy regimen 4 | 16 |
| Frontline: Therapy regimen 14 | 3 |
| Frontline: Therapy regimen 15 | 1 |
| Frontline: Therapy regimen 2 | 6 |
| Frontline: Therapy regimen 24 | 16 |
| Second line: Therapy regimen 1 | 13 |
| Second line: Therapy regimen 6 | 3 |
| Second line: Therapy regimen 7 | 23 |
| Second line: Therapy regimen 8 | 21 |
| Second line: Therapy regimen 9 | 1 |
| Second line: Therapy regimen 10 | 18 |
| Second line: Therapy regimen 11 | 7 |
| Second line: Therapy regimen 13 | 7 |
| Second line: Therapy regimen 17 | 2 |
| Second line: Therapy regimen 18 | 1 |
| Second line: Therapy regimen 19 | 1 |
| Second line: Therapy regimen 4 | 13 |
| Second line: Therapy regimen 14 | 5 |
| Second line: Therapy regimen 15 | 1 |
| Second line: Therapy regimen 2 | 5 |
| Second line: Therapy regimen 24 | 39 |
| Third line: Therapy regimen 1 | 3 |
| Third line: Therapy regimen 7 | 4 |
| Third line: Therapy regimen 8 | 3 |
| Third line: Therapy regimen 9 | 2 |
| Third line: Therapy regimen 10 | 8 |
| Third line: Therapy regimen 11 | 11 |
| Third line: Therapy regimen 13 | 3 |
| Third line: Therapy regimen 17 | 1 |
| Third line: Therapy regimen 18 | 3 |
| Third line: Therapy regimen 22 | 1 |
| Third line: Therapy regimen 4 | 2 |
| Third line: Therapy regimen 24 | 23 |
| Other treatment: Therapy regimen 6 | 1 |
| Other treatment: Therapy regimen 7 | 1 |
| Other treatment: Therapy regimen 10 | 1 |
| Other treatment: Therapy regimen 13 | 1 |
| Other treatment: Therapy regimen 18 | 5 |
| Other treatment: Therapy regimen 22 | 2 |
| Other treatment: Therapy regimen 16 | 1 |
| Other treatment: Therapy regimen 4 | 1 |
| percentage of participants | Group 2: RRHL |
|---|---|
| Palliative at Frontline | 2.6 |
| Palliative at Relapse | 43.6 |
| percentage of participants | Group 2: RRHL |
|---|---|
| PET or PET-CT scan at Baseline | 31.4 |
| PET or PET-CT scan at Frontline | 59.3 |
| PET or PET-CT scan at Relapse | 50 |
| percentage of participants | Group 2: RRHL |
|---|---|
| RT at Frontline | 17.4 |
| RT at Relapse | 22.9 |
| scans | Group 2: RRHL |
|---|---|
| Frequency of PET or PET-CT Scan at Baseline | 1.0 (1.0 to 2.0) |
| Frequency of PET or PET-CT Scan at Frontline | 1.0 (1.0 to 3.0) |
| Frequency of PET or PET-CT Scan at Relapse | 1.0 (1.0 to 9.0) |
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other.
| cycles | Group 2: RRHL |
|---|---|
| Frontline: Therapy regimen 1 | 6.0 (1.0 to 8.0) |
| Frontline: Therapy regimen 3 | 6.0 (6.0 to 6.0) |
| Frontline: Therapy regimen 6 | 6.0 (6.0 to 6.0) |
| Frontline: Therapy regimen 7 | 3.0 (1.0 to 4.0) |
| Frontline: Therapy regimen 11 | 4.0 (4.0 to 4.0) |
| Frontline: Therapy regimen 18 | 3.0 (3.0 to 3.0) |
| Frontline: Therapy regimen 4 | 6.5 (1.0 to 8.0) |
| Frontline: Therapy regimen 14 | 6.0 (6.0 to 6.0) |
| Frontline: Therapy regimen 15 | 7.0 (7.0 to 7.0) |
| Frontline: Therapy regimen 2 | 7.0 (6.0 to 8.0) |
| Frontline: Therapy regimen 24 | 3.0 (1.0 to 7.0) |
| Second line: Therapy regimen 1 | 4.0 (1.0 to 6.0) |
| Second line: Therapy regimen 6 | 5.0 (4.0 to 6.0) |
| Second line: Therapy regimen 7 | 2.0 (1.0 to 4.0) |
| Second line: Therapy regimen 8 | 2.0 (1.0 to 6.0) |
| Second line: Therapy regimen 9 | 2.0 (2.0 to 2.0) |
| Second line: Therapy regimen 10 | 3.0 (1.0 to 8.0) |
| Second line: Therapy regimen 11 | 4.0 (1.0 to 4.0) |
| Second line: Therapy regimen 13 | 4.0 (1.0 to 6.0) |
| Second line: Therapy regimen 24 | 3.0 (1.0 to 12.0) |
| Second line: Therapy regimen 17 | 3.0 (2.0 to 4.0) |
| Second line: Therapy regimen 18 | 6.0 (6.0 to 6.0) |
| Second line: Therapy regimen 19 | 2.0 (2.0 to 2.0) |
| Second line: Therapy regimen 4 | 4.0 (1.0 to 7.0) |
| Second line: Therapy regimen 14 | 3.0 (1.0 to 6.0) |
| Second line: Therapy regimen 15 | 5.0 (5.0 to 5.0) |
| Second line: Therapy regimen 2 | 6.0 (6.0 to 6.0) |
| Third line: Therapy regimen 1 | 3.0 (1.0 to 6.0) |
| Third line: Therapy regimen 7 | 4.0 (2.0 to 6.0) |
| Third line: Therapy regimen 8 | 2.0 (2.0 to 3.0) |
| Third line: Therapy regimen 9 | 4.5 (3.0 to 6.0) |
| Third line: Therapy regimen 10 | 3.5 (2.0 to 8.0) |
| Third line: Therapy regimen 11 | 2.0 (1.0 to 3.0) |
| Third line: Therapy regimen 13 | 6.0 (1.0 to 6.0) |
| Third line: Therapy regimen 18 | 2.0 (2.0 to 4.0) |
| Third line: Therapy regimen 17 | 12.0 (12.0 to 12.0) |
| Third line: Therapy regimen 22 | 43.0 (43.0 to 43.0) |
| Third line: Therapy regimen 4 | 3.5 (2.0 to 5.0) |
| Third line: Therapy regimen 24 | 3.0 (1.0 to 6.0) |
| Other treatments: Therapy regimen 6 | 1.0 (1.0 to 1.0) |
| Other treatments: Therapy regimen 8 | 2.0 (2.0 to 2.0) |
| Other treatments: Therapy regimen 10 | 4.0 (4.0 to 4.0) |
| Other treatments: Therapy regimen 13 | 6.0 (6.0 to 6.0) |
| Other treatments: Therapy regimen 18 | 6.0 (4.0 to 7.0) |
| Other treatments: Therapy regimen 22 | 12.0 (1.0 to 23.0) |
| Other treatments: Therapy regimen 16 | 4.0 (4.0 to 4.0) |
| Other treatments: Therapy regimen 4 | 5.0 (5.0 to 5.0) |
| Other treatments: Therapy regimen 24 | 6.0 (1.0 to 17.0) |
| months | Group 2: RRHL |
|---|---|
| Frontline Treatment | 5.4 (0.5 to 12.4) |
| Second line Treatment | 2.2 (0.0 to 8.5) |
| Third line Treatment | 2.1 (0.0 to 31.6) |
| Other Treatment | 9.7 (0.1 to 44.8) |
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. More than one line of treatment or therapy was selected for each participant
| percentage of participants | Group 2: RRHL |
|---|---|
| Frontline: Therapy regimen 1 | 14.3 |
| Frontline: Therapy regimen 3 | 0.0 |
| Frontline: Therapy regimen 6 | 0.0 |
| Frontline: Therapy regimen 7 | 0.0 |
| Frontline: Therapy regimen 11 | 0.0 |
| Frontline: Therapy regimen 18 | 0.0 |
| Frontline: Therapy regimen 4 | 6.3 |
| Frontline: Therapy regimen 15 | 0.0 |
| Frontline: Therapy regimen 14 | 0.0 |
| Frontline: Therapy regimen 2 | 0.0 |
| Frontline: Therapy regimen 24 | 12.5 |
| Second line: Therapy regimen 1 | 2.06 |
| Second line: Therapy regimen 6 | 0.0 |
| Second line: Therapy regimen 7 | 4.3 |
| Second line: Therapy regimen 8 | 0.0 |
| Second line: Therapy regimen 9 | 0.0 |
| Second line: Therapy regimen 10 | 5.6 |
| Second line: Therapy regimen 11 | 14.3 |
| Second line: Therapy regimen 13 | 42.9 |
| Second line: Therapy regimen 17 | 0.0 |
| Second line: Therapy regimen 18 | 0.0 |
| Second line: Therapy regimen 19 | 0.0 |
| Second line: Therapy regimen 14 | 0.0 |
| Second line: Therapy regimen 15 | 0.0 |
| Second line: Therapy regimen 2 | 0.0 |
| Second line: Therapy regimen 24 | 5.3 |
| Third line: Therapy regimen 1 | 33.3 |
| Third line: Therapy regimen 7 | 0.0 |
| Third line: Therapy regimen 8 | 0.0 |
| Third line: Therapy regimen 9 | 50.0 |
| Third line: Therapy regimen 10 | 0.0 |
| Third line: Therapy regimen 11 | 0.0 |
| Third line: Therapy regimen 13 | 33.3 |
| Third line: Therapy regimen 17 | 0.0 |
| Third line: Therapy regimen 18 | 0.0 |
| Third line: Therapy regimen 22 | 0.0 |
| Third line: Therapy regimen 4 | 0.0 |
| Third line: Therapy regimen 24 | 12.5 |
| Other treatment: Therapy regimen 6 | 0.0 |
| Other treatment: Therapy regimen 8 | 0.0 |
| Other treatment: Therapy regimen 10 | 0.0 |
| Other treatment: Therapy regimen 13 | 0.0 |
| Other treatment: Therapy regimen 18 | 0.0 |
| Other treatment: Therapy regimen 22 | 0.0 |
| Other treatment: Therapy regimen 16 | 0.0 |
| Other treatment: Therapy regimen 4 | 100.0 |
| Other treatment: Therapy regimen 24 | 11.1 |
| days | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants | 24.0 (1.0 to 902.0) |
| days | Group 2: RRHL |
|---|---|
| From end of 1st treatment post 1st relapse to subsequent treatment | 33.0 (1.0 to 148.0) |
| From end of 2nd treatment post 1st relapse to subsequent treatment | 36.5 (1.0 to 561.0) |
| Participants | Group 2: RRHL |
|---|---|
| RT Type: Whole body | 1 |
| RT Type: Involved-field | 19 |
| RT Type: Involved-site | 9 |
| RT Type: Involved-node | 10 |
| RT Site: Abdominal nodes | 2 |
| RT Site: Axillary nodes | 3 |
| RT Site: Breast | 2 |
| RT Site: Inguinal nodes | 3 |
| RT Site: Liver | 1 |
| RT Site: Mediastinal nodes | 13 |
| RT Site: Neck nodes | 7 |
| RT Site: Para-iliac nodes | 1 |
| RT Site: Pelvic nodes | 1 |
| RT Site: Soft tissue | 1 |
| RT Site: Other | 5 |
| Participants | Group 2: RRHL |
|---|---|
| RT Type: Whole body | 0 |
| RT Type: Involved-field | 24 |
| RT Type: Involved-site | 20 |
| RT Type: Involved-node | 10 |
| RT Type: Other | 1 |
| RT Site: Abdominal nodes | 2 |
| RT Site: Axillary nodes | 4 |
| RT Site: Bone lesions | 8 |
| RT Site: Brain | 1 |
| RT Site: Cervix | 1 |
| RT Site: Inguinal nodes | 2 |
| RT Site: Mediastinal nodes | 17 |
| RT Site: Neck nodes | 9 |
| RT Site: Para-iliac nodes | 1 |
| RT Site: Pelvic nodes | 3 |
| RT Site: Supraclavicular nodes | 2 |
| RT Site: Other | 5 |
| Gray | Group 2: RRHL |
|---|---|
| Frontline | 36.0 ± 9.77 |
| Relapse/refractory | 30.5 ± 10.37 |
| scans | Group 2: RRHL |
|---|---|
| Baseline | 1.1 ± 0.23 |
| Frontline | 1.4 ± 0.57 |
| Relapse | 2.0 ± 1.58 |
Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other. Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan.
| Participants | Group 2: RRHL |
|---|---|
| Salvage Regimens: Pre-SCT, Therapy regimen 8 | 1 |
| Salvage Regimens: Pre-SCT, Therapy regimen 10 | 2 |
| Salvage Regimens: Pre-SCT, Therapy regimen 11 | 1 |
| Salvage Regimens: Pre-SCT, Therapy regimen 12 | 5 |
| Salvage Regimens: Pre-SCT, Therapy regimen 18 | 3 |
| Salvage Regimens: Pre-SCT, Therapy regimen 19 | 1 |
| Salvage Regimens: Pre-SCT, Therapy regimen 16 | 1 |
| Salvage Regimens: Pre-SCT, Therapy regimen 24 | 23 |
| Salvage Regimens: Post-SCT, Therapy regimen 10 | 1 |
| Salvage Regimens: Post-SCT, Therapy regimen 11 | 1 |
| Salvage Regimens: Post-SCT, Therapy regimen 18 | 3 |
| Salvage Regimens: Post-SCT, Therapy regimen 19 | 1 |
| Salvage Regimens: Post-SCT, Therapy regimen 24 | 2 |
| Conditioning Regimens: BEAM | 132 |
| Conditioning Regimens: CBV | 22 |
| Conditioning Regimens: BeEAM | 6 |
| Conditioning Regimens: Gemcitabine/Bu/Mel | 1 |
| Conditioning Regimens: Other | 55 |
| Conditioning Regimens: Unknown | 3 |
| Consolidation Therapy : Post -SCT | 4 |
Known risk factors for relapse after ASCT included time to first relapse less than or equal to (\<=) 3 months, stage IV disease at relapse, bulky disease \>=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission \[PR\] or PET positivity), performance status (eastern Cooperative oncology group \[ECOG\]) \>=1. The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities).
| Participants | Group 2: RRHL |
|---|---|
| Time to first relapse <=3 months | 19 |
| Stage IV disease at relapse | 81 |
| Bulky disease >=5 cm at relapse | 47 |
| Extranodal disease | 83 |
| Inadequate response to salvage chemotherapy | 63 |
| Performance status (ECOG) >=1 | 73 |
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other.
| cycles | Group 2: RRHL |
|---|---|
| Therapy regimen 1 | 3.0 (1.0 to 8.0) |
| Therapy regimen 6 | 5.5 (3.0 to 8.0) |
| Therapy regimen 7 | 3.0 (1.0 to 6.0) |
| Therapy regimen 8 | 3.0 (1.0 to 4.0) |
| Therapy regimen 9 | 2.0 (1.0 to 4.0) |
| Therapy regimen 10 | 3.0 (1.0 to 6.0) |
| Therapy regimen 11 | 3.0 (1.0 to 4.0) |
| Therapy regimen 12 | 1.0 (1.0 to 5.0) |
| Therapy regimen 13 | 5.0 (1.0 to 6.0) |
| Therapy regimen 17 | 8.0 (8.0 to 8.0) |
| Therapy regimen 18 | 6.0 (2.5 to 16.0) |
| Therapy regimen 19 | 4.0 (1.0 to 9.0) |
| Therapy regimen 22 | 6.5 (5.0 to 8.0) |
| Therapy regimen 23 | 21.0 (21.0 to 21.0) |
| Therapy regimen 16 | 3.0 (2.0 to 6.0) |
| Therapy regimen 4 | 4.0 (2.0 to 4.0) |
| Therapy regimen 14 | 1.0 (1.0 to 1.0) |
| Therapy regimen 2 | 2.0 (2.0 to 2.0) |
| Therapy regimen 24 | 2.3 (1.0 to 16.0) |
| percentage of participants | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT | 1.4 |
| months | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT | 11.1 (6.3 to 14.5) |
| Participants | Group 2: RRHL |
|---|---|
| Bone marrow | 36 |
| Peripheral | 182 |
| days | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT | 182.5 (12.0 to 1021.0) |
| cells per kilogram | Group 2: RRHL |
|---|---|
| Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT | 211.2 ± 248.65 |
| months | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT | 9.9 (2.1 to 78.4) |
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab.
| Participants | Group 2: RRHL |
|---|---|
| Frontline: Therapy regimen 1 | 57 |
| Frontline: Therapy regimen 7 | 1 |
| Frontline: Therapy regimen 10 | 1 |
| Frontline: Therapy regimen 11 | 1 |
| Frontline: Therapy regimen 4 | 4 |
| Frontline: Therapy regimen 2 | 2 |
| Frontline: Therapy regimen 24 | 3 |
| Second line: Therapy regimen 7 | 9 |
| Second line: Therapy regimen 8 | 28 |
| Second line: Therapy regimen 10 | 10 |
| Second line: Therapy regimen 11 | 4 |
| Second line: Therapy regimen 12 | 1 |
| Second line: Therapy regimen 13 | 2 |
| Second line: Therapy regimen 18 | 1 |
| Second line: Therapy regimen 4 | 4 |
| Second line: Therapy regimen 24 | 5 |
| Third line: Therapy regimen 7 | 2 |
| Third line: Therapy regimen 8 | 3 |
| Third line: Therapy regimen 9 | 3 |
| Third line: Therapy regimen 10 | 6 |
| Third line: Therapy regimen 11 | 9 |
| Third line: Therapy regimen 12 | 3 |
| Third line: Therapy regimen 13 | 1 |
| Third line: Therapy regimen 18 | 9 |
| Third line: Therapy regimen 22 | 1 |
| Third line: Therapy regimen 23 | 1 |
| Third line: Therapy regimen 16 | 4 |
| Third line: Therapy regimen 4 | 1 |
| Third line: Therapy regimen 24 | 13 |
| Pre-SCT: Therapy regimen 10 | 2 |
| Pre-SCT: Therapy regimen 12 | 3 |
| Pre-SCT: Therapy regimen 18 | 2 |
| Pre-SCT: Therapy regimen 19 | 1 |
| Pre-SCT: Therapy regimen 14 | 1 |
| Pre-SCT: Therapy regimen 24 | 9 |
| Post-SCT: Therapy regimen 18 | 2 |
| Other treatment: Therapy regimen 7 | 1 |
| Other treatment: Therapy regimen 9 | 1 |
| Other treatment: Therapy regimen 10 | 2 |
| Other treatment: Therapy regimen 11 | 1 |
| Other treatment: Therapy regimen 17 | 1 |
| Other treatment: Therapy regimen 18 | 7 |
| Other treatment: Therapy regimen 19 | 7 |
| Other treatment: Therapy regimen 22 | 5 |
| Other treatment: Therapy regimen 23 | 2 |
| Other treatment: Therapy regimen 16 | 1 |
| Other treatment: Therapy regimen 4 | 1 |
| Other treatment: Therapy regimen 24 | 15 |
Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab.
| percentage of participants | Group 2: RRHL |
|---|---|
| Therapy regimen 9 | 12.5 |
| Therapy regimen 10 | 12.5 |
| Therapy regimen 11 | 12.5 |
| Therapy regimen 12 | 12.5 |
| Therapy regimen 18 | 12.5 |
| Therapy regimen 19 | 12.5 |
| Therapy regimen 22 | 12.5 |
| Other | 75.0 |
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD.
| cycles | Group 2: RRHL |
|---|---|
| Frontline: Therapy regimen 1 | 6.0 (2.0 to 8.0) |
| Frontline: Therapy regimen 7 | 2.0 (2.0 to 2.0) |
| Frontline: Therapy regimen 10 | 2.0 (2.0 to 2.0) |
| Frontline: Therapy regimen 11 | 2.0 (2.0 to 2.0) |
| Frontline: Therapy regimen 4 | 6.0 (6.0 to 8.0) |
| Frontline: Therapy regimen 2 | 7.0 (6.0 to 8.0) |
| Frontline: Therapy regimen 24 | 2.0 (1.0 to 4.0) |
| Second line: Therapy regimen 7 | 2.0 (1.0 to 6.0) |
| Second line: Therapy regimen 8 | 3.0 (1.0 to 6.0) |
| Second line: Therapy regimen 10 | 3.0 (1.0 to 3.0) |
| Second line: Therapy regimen 11 | 3.0 (3.0 to 4.0) |
| Second line: Therapy regimen 12 | 1.0 (1.0 to 1.0) |
| Second line: Therapy regimen 13 | 3.5 (1.0 to 6.0) |
| Second line: Therapy regimen 18 | 3.0 (3.0 to 3.0) |
| Second line: Therapy regimen 4 | 4.0 (2.0 to 6.0) |
| Second line: Therapy regimen 24 | 4.0 (2.0 to 8.0) |
| Third line: Therapy regimen 7 | 1.5 (1.0 to 2.0) |
| Third line: Therapy regimen 8 | 2.0 (2.0 to 3.0) |
| Third line: Therapy regimen 9 | 6.0 (2.0 to 6.0) |
| Third line: Therapy regimen 10 | 3.0 (1.0 to 6.0) |
| Third line: Therapy regimen 11 | 3.0 (1.0 to 4.0) |
| Third line: Therapy regimen 12 | 2.0 (1.0 to 4.0) |
| Third line: Therapy regimen 13 | 6.0 (6.0 to 6.0) |
| Third line: Therapy regimen 18 | 5.0 (3.0 to 16.0) |
| Third line: Therapy regimen 22 | 8.0 (8.0 to 8.0) |
| Third line: Therapy regimen 23 | 1.0 (1.0 to 1.0) |
| Third line: Therapy regimen 16 | 3.0 (3.0 to 6.0) |
| Third line: Therapy regimen 4 | 3.0 (3.0 to 3.0) |
| Pre-SCT: Therapy regimen 10 | 2.0 (2.0 to 2.0) |
| Pre-SCT: Therapy regimen 12 | 1.0 (1.0 to 1.0) |
| Pre-SCT: Therapy regimen 18 | 7.5 (5.0 to 10.0) |
| Pre-SCT: Therapy regimen 19 | 6.0 (6.0 to 6.0) |
| Pre-SCT: Therapy regimen 14 | 1.0 (1.0 to 1.0) |
| Pre-SCT: Therapy regimen 24 | 1.0 (1.0 to 1.0) |
| Post-SCT: Therapy regimen 18 | 9.0 (6.0 to 12.0) |
| Other treatment: Therapy regimen 7 | 3.0 (3.0 to 3.0) |
| Other treatment: Therapy regimen 9 | 4.0 (4.0 to 4.0) |
| Other treatment: Therapy regimen 10 | 2.5 (2.0 to 3.0) |
| Other treatment: Therapy regimen 11 | 4.0 (4.0 to 4.0) |
| Other treatment: Therapy regimen 17 | 8.0 (8.0 to 8.0) |
| Other treatment: Therapy regimen 18 | 12.0 (2.0 to 16.0) |
| Other treatment: Therapy regimen 19 | 4.0 (2.0 to 9.0) |
| Other treatment: Therapy regimen 22 | 7.0 (5.0 to 26.0) |
| Other treatment: Therapy regimen 23 | 23.0 (21.0 to 25.0) |
| Other treatment: Therapy regimen 16 | 2.0 (2.0 to 2.0) |
| Other treatment: Therapy regimen 4 | 2.0 (2.0 to 2.0) |
| Other treatment: Therapy regimen 24 | 4.0 (1.0 to 16.0) |
| months | Group 2: RRHL |
|---|---|
| Frontline Treatment | 5.9 (0.0 to 11.9) |
| Second line Treatment | 2.0 (0.0 to 9.4) |
| Third line Treatment | 2.0 (0.1 to 13.2) |
| Pre-SCT Treatment | 0.2 (0.0 to 6.0) |
| Post-SCT Treatment | 7.2 (5.6 to 8.8) |
| Other Treatment | 4.0 (0.7 to 18.5) |
| months | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT | 16.0 (2.9 to 53.8) |
| months | Group 2: RRHL |
|---|---|
| From ASCT to 1st treatment | 16.0 (2.9 to 53.8) |
| From ASCT to 2nd treatment | 19.1 (9.1 to 87.4) |
| From ASCT to 3rd treatment | 28.1 (17.7 to 90.9) |
| From completion of 1st treatment to next treatment | 63.0 (25.0 to 1596.0) |
| From completion of 2nd treatment to next treatment | 87.0 (59.0 to 544.0) |
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned.
| percentage of participants | Group 2: RRHL |
|---|---|
| PET-CT scan: Baseline | 23.6 |
| PET-CT scan: Frontline | 54.5 |
| PET-CT scan: Relapse and /or refractory | 60.0 |
| CT scan: Baseline | 47.9 |
| CT scan: Frontline | 60.4 |
| CT scan: Relapse and /or refractory | 70.8 |
| Radiotherapy: Frontline | 22.2 |
| Radiotherapy: Relapse/refractory | 36.5 |
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned.
| scans | Group 2: RRHL |
|---|---|
| PET or PET-CT scan: Baseline | 1.0 ± 0.00 |
| PET or PET-CT scan: Frontline | 2.0 ± 1.26 |
| PET or PET-CT scan: Relapse /refractory | 5.6 ± 3.62 |
| CT Scan: Baseline | 1.0 ± 0.21 |
| CT Scan: Frontline | 2.6 ± 2.26 |
| CT Scan: Relapse/refractory | 4.3 ± 4.37 |
| Participants | Group 2: RRHL |
|---|---|
| Frontline: Whole body | 1 |
| Frontline: Involved-field radiotherapy | 8 |
| Frontline: Involved-site radiotherapy | 4 |
| Frontline: Involved-node radiotherapy | 2 |
| Relapse/refractory: Whole body | 1 |
| Relapse/refractory: Involved-field radiotherapy | 21 |
| Relapse/refractory: Involved-site radiotherapy | 4 |
| Relapse/refractory: Involved-node radiotherapy | 3 |
| Relapse/refractory: Other | 1 |
| Participants | Group 2: RRHL |
|---|---|
| Frontline: Axillary nodes | 1 |
| Frontline: Bone lesions | 1 |
| Frontline: Mediastinal nodes | 4 |
| Frontline: Neck nodes | 2 |
| Frontline: Other | 7 |
| Relapse/refractory: Abdominal nodes | 4 |
| Relapse/refractory: Axillary nodes | 4 |
| Relapse/refractory: Bone lesions | 3 |
| Relapse/refractory: Mediastinal nodes | 12 |
| Relapse/refractory: Neck nodes | 5 |
| Relapse/refractory: Other | 2 |
| Participants | Group 2: RRHL |
|---|---|
| Frontline: Radical/Cure Intent | 14 |
| Frontline: Other | 1 |
| Relapse/refractory: Radical/Cure Intent | 23 |
| Relapse/refractory: Palliative Intent | 5 |
| Relapse/refractory: Other | 2 |
| Gray | Group 2: RRHL |
|---|---|
| Total Dose of RT at Frontline | 32.0 ± 7.28 |
| Total Dose of RT at Relapse/refractory | 33.0 ± 6.96 |
| percentage of participants | Group 2: RRHL |
|---|---|
| Undergoing subsequent ASCTs | 38.1 |
| Undergoing allo-SCT | 4.8 |
| ASCTs | Group 2: RRHL |
|---|---|
| Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT | 1.0 (1.0 to 2.0) |
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. PD was defined as any new lesion or increase by \>= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
| months | Group 1: cHL |
|---|---|
| Group 1, cHL: Median PFS | NA (NA to NA) |
Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir.
| participants | Group 1: cHL |
|---|---|
| CR | 968 |
| PR | 356 |
| SD | 80 |
| PD | 109 |
| Other | 85 |
Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir.
| participants | Group 2: RRHL |
|---|---|
| Frontline: CR | 131 |
| Frontline: PR | 133 |
| Frontline: SD | 40 |
| Frontline: PD | 98 |
| Frontline: Other | 24 |
| Second line: CR | 107 |
| Second line: PR | 113 |
| Second line: SD | 32 |
| Second line: PD | 80 |
| Second line: Other | 42 |
| Third line: CR | 46 |
| Third line: PR | 38 |
| Third line: SD | 22 |
| Third line: PD | 48 |
| Third line: Other | 24 |
| Pre-SCT: CR | 14 |
| Pre-SCT: PR | 12 |
| Pre-SCT: SD | 2 |
| Pre-SCT: PD | 4 |
| Post-SCT: CR | 5 |
| Pre-SCT: Other | 18 |
| Post-SCT: PR | 1 |
| Post-SCT: SD | 1 |
| Post-SCT: PD | 2 |
| Post-SCT: Other | 1 |
| Other line: CR | 17 |
| Other line: PR | 17 |
| Other line: SD | 10 |
| Other line: PD | 15 |
| Other line: Other | 10 |
Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir.
| months | Group 1: cHL | Group 2: RRHL |
|---|---|---|
| Mean Duration of Best Response | NA (NA to NA) | 51.08 (27.07 to NA) |
Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact.
| months | Group 1: cHL | Group 2: RRHL |
|---|---|---|
| Median Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported. 5 year overall survival data were reported only for participants who had \>5 year observation periods.
| percentage of participants | Group 1: cHL |
|---|---|
| At 1 year | 95.65 (94.52 to 96.56) |
| At 5 years | 84.74 (82.75 to 86.52) |
Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported. 5 year overall survival data were reported only for participants who had \>5 year observation periods.
| percentage of participants | Group 2: RRHL |
|---|---|
| At 1 year | 89.15 (84.48 to 92.48) |
| At 5 years | 70.68 (64.10 to 76.28) |
| Participants | Group 1: cHL |
|---|---|
| Inpatient Hospital Admissions | 864 |
| Emergency Room Visits | 357 |
| Outpatient Visits | 1135 |
| Participants | Group 1: cHL |
|---|---|
| Chemotherapy | 563 |
| Radiotherapy | 39 |
| Stem cell transplant | 146 |
| Adverse event | 287 |
| Unknown | 37 |
| Other | 384 |
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits.
| days | Group 1: cHL |
|---|---|
| Overall length of stay | 15.1 ± 41.02 |
| Length of stay by unit/ward: General | 13.2 ± 41.86 |
| Length of stay by unit/ward: High dependency/intermediate | 20.2 ± 17.29 |
| Length of stay by unit/ward: Intensive Care Unit | 28.0 ± 26.14 |
| Length of stay by unit/ward: Bone marrow transplant unit | 32.7 ± 39.70 |
| Participants | Group 1: cHL |
|---|---|
| RT received | 357 |
| Scan/procedure: Chest x-Ray | 427 |
| Scan/procedure: Magnetic resonance imaging (MRI) | 92 |
| Scan/procedure: Needle biopsy | 273 |
| Scan/procedure: Bone scan | 19 |
| Scan/procedure: Bone marrow aspiration | 997 |
| Scan/procedure: Flow cytometry | 61 |
| Scan/procedure: Other scan procedures | 315 |
| Received G-CSF/ other high cost medications | 794 |
| Received Pegylated G-CSF | 143 |
| days | Group 1: cHL |
|---|---|
| Courses: G-CSF treatment/other high cost medicines | 5.6 ± 6.99 |
| Courses: Pegylated G-CSF | 2.5 ± 2.99 |
Each participant had more than one category presented for salvage therapy and ASCT.
| Participants | Group 2: RRHL |
|---|---|
| Salvage Therapy: Inpatient Hospital Admissions | 175 |
| Salvage Therapy: Emergency Room Visits | 44 |
| Salvage Therapy: Outpatient Visits | 185 |
| ASCT: Inpatient Hospital Admissions | 5 |
| ASCT: Emergency Room Visits | 2 |
| ASCT: Outpatient Visits | 4 |
Each participant had more than one category presented for salvage therapy and ASCT.
| Participants | Group 2: RRHL |
|---|---|
| Salvage Therapy: Chemotherapy | 144 |
| Salvage Therapy: Radiotherapy | 6 |
| Salvage Therapy: Stem cell transplant | 50 |
| Salvage Therapy: Adverse event | 36 |
| Salvage Therapy: Unknown | 6 |
| Salvage Therapy: Other | 51 |
| ASCT: Chemotherapy | 2 |
| ASCT: Adverse event | 3 |
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. Each participant had more than one category presented for salvage therapy and ASCT.
| days | Group 2: RRHL |
|---|---|
| Salvage Therapy: Overall length of stay | 13.6 ± 16.30 |
| Salvage Therapy: General | 11.4 ± 15.79 |
| Salvage Therapy: High dependency/intermediate | 25.8 ± 18.24 |
| Salvage Therapy: Intensive Care Unit | 13.0 ± 7.07 |
| Salvage Therapy: Bone marrow transplant unit | 25.8 ± 10.08 |
| ASCT: Overall length of stay | 7.8 ± 4.54 |
| ASCT: General | 4.9 ± 1.23 |
| ASCT: High dependency/intermediate | 10.5 ± 6.36 |
| ASCT: Intensive Care Unit | 18.0 ± NA |
Each participant had more than one category presented for salvage therapy and ASCT. Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures.
| Participants | Group 2: RRHL |
|---|---|
| Salvage Therapy: Chest x-Ray | 63 |
| Salvage Therapy: Magnetic resonance imaging | 8 |
| Salvage Therapy: Needle biopsy | 19 |
| Salvage Therapy: Bone scan | 3 |
| Salvage Therapy: Bone marrow aspiration | 43 |
| Salvage Therapy: Flow cytometry | 4 |
| Salvage Therapy: Other scan procedures | 40 |
| Salvage Therapy: G-CSF/ other high cost medications | 150 |
| Salvage Therapy: Pegylated G-CSF | 17 |
| ASCT: G-CSF/ other high cost medications | 6 |
| ASCT: Pegylated G-CSF | 1 |
| days | Group 2: RRHL |
|---|---|
| Salvage Therapy: G-CSF treatment/other high cost medicines | 2.8 ± 2.78 |
| Salvage Therapy: Pegylated G-CSF | 2.6 ± 2.90 |
| ASCT: G-CSF treatment/other high cost medicines | 4.2 ± 2.64 |
| ASCT: Pegylated G-CSF | 6.0 ± NA |
Collected over From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months]). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: cHL | 243/1,598 (15.2%) | 303/1,598 (19%) | 642/1,598 (40.2%) |
| Group 2: RRHL | 136/426 (31.9%) | 103/426 (24.2%) | 187/426 (43.9%) |
| Event | Group 1: cHL | Group 2: RRHL |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 69/1598 | 25/426 |
| PyrexiaGeneral disorders | 46/1598 | 16/426 |
| PneumoniaInfections and infestations | 33/1598 | 6/426 |
| NeutropeniaBlood and lymphatic system disorders | 30/1598 | 8/426 |
| Neutropenic sepsisInfections and infestations | 8/1598 | 6/426 |
| Herpes zosterInfections and infestations | 7/1598 | 4/426 |
| AnaemiaBlood and lymphatic system disorders | 15/1598 | 3/426 |
| PancytopeniaBlood and lymphatic system disorders | 5/1598 | 3/426 |
| SepsisInfections and infestations | 6/1598 | 3/426 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/1598 | 3/426 |
| Event | Group 1: cHL | Group 2: RRHL |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 256/1598 | 80/426 |
| PyrexiaGeneral disorders | 68/1598 | 45/426 |
| Febrile neutropeniaBlood and lymphatic system disorders | 56/1598 | 29/426 |
| LeukopeniaBlood and lymphatic system disorders | 68/1598 | 24/426 |
| NauseaGastrointestinal disorders | 70/1598 | 24/426 |
| AnaemiaBlood and lymphatic system disorders | 46/1598 | 20/426 |
| ThrombocytopeniaBlood and lymphatic system disorders | 27/1598 | 20/426 |
| VomitingGastrointestinal disorders | 60/1598 | 20/426 |
| Neutrophil count decreasedInvestigations | 35/1598 | 15/426 |
| DiarrhoeaGastrointestinal disorders | 28/1598 | 14/426 |
The full analysis set (FAS) included all participants who were eligible for cHL or RRHL group including the common participants in both the groups.
| Age, Customized(Participants) | Group 1: cHL | Group 2: RRHL | Total |
|---|---|---|---|
| Less than (<) 60 years | 1382 | 94 | 1476 |
| Greater than or equal to (>=) 60 years | 216 | 11 | 227 |
| Sex: Female, Male(Participants) | Group 1: cHL | Group 2: RRHL | Total |
|---|---|---|---|
| Female | 719 | 41 | 760 |
| Male | 879 | 64 | 943 |
| Race/Ethnicity, Customized(Participants) | Group 1: cHL | Group 2: RRHL | Total |
|---|---|---|---|
| Black or African American | 62 | 2 | 64 |
| American Indian or Alaska Native | 22 | 0 | 22 |
| Asian | 560 | 29 | 589 |
| White or Caucasian | 525 | 57 | 582 |
| Not Reported | 197 | 12 | 209 |
| Other | 232 | 5 | 237 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Nov 2017 to primary completion in Oct 2019, 23 months.
Results were first posted in Jun 2021, 1 year 7 months after primary completion.
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