A Phase 2 interventional study of Induction with Brentuximab vedotin (BV) and Induction without Brentuximab Vedotin in Hodgkin Lymphoma, Adult, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Recruiting at 19 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Phase 2, Interventional, and Treatment
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Among 80 studies testing Brentuximab Vedotin in Hodgkin Disease — 14 open to participants now, 28 under way, 8 of them phase 3. Brentuximab Vedotin · Hodgkin Disease.
Among the 80 studies testing Brentuximab Vedotin in Hodgkin Disease, this one is the 13th largest by planned enrollment, is the only one that started in 2020, is one of 41 in phase 2, reaches primary completion later than 13 of the 27 other live ones, and was the 65th registered.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
Browse Hodgkin Disease studies →14 of the 80 studies testing Brentuximab Vedotin in Hodgkin Disease are open now, in 12 countries. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 18+
University of Miami · Sites in United States
Ages 18–60
Children's Cancer Group, China · Sites in China
Ages 2–35
Takeda · Sites in India
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Brentuximab Vedotin: first FDA approval 2011 (ADCETRIS), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 136 Hodgkin Disease studies recruiting now, 73 (54%) set no upper age limit and 51 (38%) stop at 75 or younger; 46 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
80 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 56 · Phase 3 11 · Phase 4 2
First in 2006; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Median enrollment 52 across the 80 interventional studies. Of the 46 that completed or were terminated, 26 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 80 have an industry lead sponsor. The 10 most frequent:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea has 4 studies filed under Hodgkin Disease — fewer than ten, so there is no comparison to draw.
7 of the studies testing Brentuximab Vedotin in Hodgkin Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05180097Canadian Cancer Trials GroupPembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma | 2026-12-31 |
| NCT03755804St. Jude Children's Research HospitalPediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 | 2027-01-01 |
| NCT06377566Memorial Sloan Kettering Cancer CenterA Study of BV-AVD in People With Bulky Hodgkin Lymphoma | 2027-04 |
| NCT04561206City of Hope Medical CenterBrentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma | 2027-10-02 |
| NCT05404945University of VirginiaFitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above | 2027-10-03 |
Add all 7 to your calendar (.ics) → With an account.
Among the 80 studies testing Brentuximab Vedotin in Hodgkin Disease, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy
A phase IIb open label multi-center trial in patients with refractory / relapsed cHL.
Patients are randomized (1:1) to receive:
Or
Stem cell collection will be performed in all patients according to institutional guidelines, but preferably after the first / second cycle of ESHAP-BV or ESHAP.
Patients attaining a mCR (Deauville 1, 2) after receiving 3 cycles of ESHAP-BV, will receive up to 13 cycles of BV consolidation (administered every 3 weeks, over 39 weeks).
Patients who were randomized to ESHAP and attained a mCR after receiving 3 cycles will receive up to 16 cycles of BV (same dosage and time intervals).
Patients who attained less than mCR following ESHAP-BV/ESHAP they will be taken out of the trial and will be treated according to their physician's clinical decision. However, they will be followed in order to evaluate their clinical outcome in terms of ORR, CR rate, TTNT2 and OS, that will be analyzed the study separately.
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.
Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 Cycles ESHAP ( 21 days) : Etoposide \[40 mg/m2/ day IV, D1-4\], Solumedrol \[250 mg/day IV, D1-4\], High dose Ara-C \[2 g/m2 IV, D5\] Cisplatinum \[25 mg/m2/day IV, D1-4\]
Drug: Induction without Brentuximab Vedotin · Drug: Consolidation with Brentuximab Vedotin
3 Cycles of Brentuximab VEedotin + ESHAP ( 21 days) : Etoposide \[40 mg/m2/ day IV, D1-4\], Solumedrol \[250 mg/day IV, D1-4\], High dose Ara-C \[2 g/m2 IV, D5\] Cisplatinum \[25 mg/m2/day IV, D1-4\] Brentuximab Vedotin \[1.8 mg/kg IV, D1\]
Drug: Induction with Brentuximab vedotin (BV) · Drug: Consolidation with Brentuximab Vedotin
Drug page: Brentuximab Vedotin
3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV
Also known as: Adcetris treatment + ESHAP as salvage therapy
3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy
Also known as: ESHAP treatment as salvage therapy
Drug page: Brentuximab Vedotin
Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)
Also known as: Adcetris treatment as consolidation
PET-CT result
PET-CT negative, Deauville scores 1 and 2
Time frame: 4-6 weeks after the Cycle 3 started (each cycle is 21 days)
progression-free survival (PFS)
Evaluation of patient without progression of disease
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response
Lenght of time between date of evidence response and progression of disease or death
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Overall Survival (OS)
Time from entry onto the clinical trial (random assignment in a phase III study) until death as a result of any cause.
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response (DOR)
Time from first documentation of CR or PR to disease progression
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Safety and tolerability
AEs, fertility,infections, and secondary malignancies
Time frame: At the end of the 3 years of of last dose of consoldation Brentuximab VEdotin treatment
Started Jun 2020 (actual). Primary completion is estimated for Aug 2026, 74 months after the start.
Of 183 non-industry phase 2 interventional studies under Hodgkin Disease, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 115. This study's planned 74 months is close to that.
Counting every sponsor, half of 206 studies reached it within 75 months; a quarter within 42 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Brentuximab Vedotin
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea