A Phase 1/2 interventional study of Brentuximab vedotin in Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large-cell Lymphoma, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 18 sites in 8 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Millennium Pharmaceuticals, Inc. (part of Takeda) · Phase 1/2, Interventional, and Treatment
The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.
The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat children who have relapsed or refractory (r/r) anaplastic large-cell lymphoma (sALCL) or Hodgkin lymphoma (HL). This study will look at the maximum tolerated dose and/or recommended phase 2 dose, safety and pharmacokinetics of brentuximab vedotin along with overall response of people who took brentuximab vedotin.
The study enrolled 36 patients. In the phase 1 portion of the study, 12 participants were enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Once the maximum tolerated dose and/or recommended phase 2 dose and pharmacokinetics of brentuximab vedotin was reached, participants were enrolled by diagnosis into two phase 2 study arms: relapsed or refractory sALCL or relapsed or refractory HL and received brentuximab vedotin 1.8 mg/kg as 30-minute IV on Day 1 of every 21-day cycle for up to 16 cycles. One participant received a maximum of 20 cycles at the joint discretion of the sponsor and the investigator for continued clinical benefit.
This multicenter trial is being conducted worldwide. The overall time to participate in this study is approximately 5 years. Participants made multiple visits to the clinic, and were contacted by telephone every 12 weeks for 12 months after the end of treatment (EOT) for progression free survival and then every 6 months until death, study closure, or 2 years after enrollment of the last participant for overall survival.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Millennium Pharmaceuticals, Inc. is the lead sponsor of 178 studies on the registry; none are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 73 (99%) have results posted.
First submitted after Millennium Pharmaceuticals, Inc. became part of Takeda.
Compared within Hodgkin Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity. Dose was escalated up to 1.8 mg/kg using a 3 + 3 dose escalation design to determine a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) depending upon the dose limiting toxicity (DLT).
Drug: Brentuximab vedotin
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there is evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Drug: Brentuximab vedotin
Brentuximab vedotin IV infusion
Also known as: SGN-35, ADCETRIS
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Time frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)
Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
Time frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)
Blood samples were collected and tested for conjugated and unconjugated antibodies.
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)
Blood samples were collected and tested for MMAE plasma concentrations.
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Overall Response Rate (ORR) (Phase 1 and 2)
Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)
Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.
Time frame: Baseline up to EOT (Up to 15 months)
Overall Response Rate (ORR) (Phase 1)
Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)
Time to Progression (TTP) (Phase 1 and 2)
TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)
Time to Response (Phase 1 and 2)
Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)
Duration of Response (DOR) (Phase 1 and 2)
DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)
Event Free Survival (EFS) (Phase 1 and 2)
EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)
Progression Free Survival (PFS) (Phase 1 and 2)
PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Time frame: Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)
Overall Survival (OS) (Phase 1 and 2)
OS is the time in months from start of study treatment to date of death due to any cause.
Time frame: Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time frame: From the first dose through 30 days after the last dose of study medication (up to 15 months)
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Time frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)
Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
Time frame: From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Blood samples were collected and tested for conjugated and unconjugated antibodies.
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)
Blood samples were collected and tested for MMAE plasma concentrations.
Time frame: Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Participants took part in the study at 12 investigative sites in United States, France, Germany, Netherlands, United Kingdom, Italy, Spain and Mexico from 16-April-2012 to 12-April-2018.
| Milestone | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Started | 3 | 16 | 17 |
| Completed | 0 | 2 | 3 |
| Not completed | 3 | 14 | 14 |
| Withdrew: Withdrawal by patient | 0 | 2 | 0 |
| Withdrew: Death | 1 | 6 | 2 |
| Withdrew: Completed post treatment followup (ptfu) | 2 | 0 | 1 |
| Withdrew: Alive at last follow-up | 0 | 6 | 11 |
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| TEAE | 3 | 9 |
| SAE | 0 | 4 |
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| Gamma-glutamyltransferase increased | 0 | 1 |
| Transaminases increased | 0 | 1 |
| Lymphocyte count decreased | 1 | 1 |
| Neutrophil count decreased | 0 | 1 |
| Blood bicarbonate decreased | 0 | 1 |
| Weight decreased | 0 | 1 |
| Hypocalaemia | 0 | 2 |
| Hyperuricaemia | 0 | 1 |
Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1) | 0 | 0 |
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
No measurements were reported for this outcome.
Blood samples were collected and tested for conjugated and unconjugated antibodies.
No measurements were reported for this outcome.
Blood samples were collected and tested for MMAE plasma concentrations.
No measurements were reported for this outcome.
Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
| percentage of participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Overall Response Rate (ORR) (Phase 1 and 2) | 0 (0 to 71) | 47 (21 to 73) | 53 (28 to 77) |
Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| ATA status: Transiently positive | 1 | 4 | 7 |
| ATA status: Persistently positive | 0 | 2 | 0 |
| nATA status: Positive | 0 | 5 | 4 |
Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
| percentage of participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| Overall Response Rate (ORR) (Phase 1) | 0 (0 to 71) | 63 (24 to 91) |
TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.
| months | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Time to Progression (TTP) (Phase 1 and 2) | 2.7 (1.4 to 2.8) | 4.8 (1.2 to NA) | 6.2 (2.8 to NA) |
Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
| months | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Time to Response (Phase 1 and 2) | NA (NA to NA) | 2.7 (1.3 to NA) | 1.5 (1.2 to NA) |
DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
| months | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Duration of Response (DOR) (Phase 1 and 2) | — | NA (2.2 to NA) | 30.3 (3.4 to 30.3) |
EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
| months | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Event Free Survival (EFS) (Phase 1 and 2) | 2.7 (1.4 to 2.8) | 2.1 (1.2 to 4.8) | 4.8 (2.8 to 7.4) |
PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
| months | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Progression Free Survival (PFS) (Phase 1 and 2) | 2.7 (1.4 to 2.8) | 3.8 (1.2 to NA) | 6.2 (2.8 to 31.5) |
OS is the time in months from start of study treatment to date of death due to any cause.
| months | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Overall Survival (OS) (Phase 1 and 2) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| TEAEs | 3 | 16 | 17 |
| SAEs | 0 | 7 | 1 |
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Gamma-glutamyltransferase increased | 0 | 2 | 0 |
| Alanine aminotransferase increased | 0 | 1 | 0 |
| Aspartate aminotransferase increased | 0 | 1 | 0 |
| Transaminases increased | 0 | 1 | 0 |
| Lymphocyte count decreased | 1 | 0 | 2 |
| Neutrophil count decreased | 0 | 0 | 2 |
| White blood cell count decreased | 0 | 0 | 1 |
| Blood bicarbonate decreased | 0 | 1 | 0 |
| Weight decreased | 0 | 0 | 1 |
| C-reactive protein increased | 0 | 1 | 0 |
| Blood alkaline phosphatase increased | 0 | 1 | 0 |
Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
| Participants | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2) | 0 | 0 | 0 |
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
| ug/mL | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| Cycle 1 Day 1, Pre-Dose | — | NA ± NA |
| Cycle 1 Day 1, 5 Minutes Post-Dose | 23.1 ± 3.46 | 31.8 ± 12.4 |
| Cycle 1 Day 2, 24 Hours Post-Dose | 9.50 ± 1.73 | 13.0 ± 5.34 |
| Cycle 1 Day 3, 48 Hours Post-Dose | 5.67 ± 0.924 | 12.0 ± 16.3 |
| Cycle 1 Day 5, 96 Hours Post-Dose | 3.50 ± 1.41 | 8.68 ± 13.4 |
| Cycle 1 Day 14, 312 Hours Post-Dose | 0.844 ± 0.309 | 2.19 ± 3.44 |
| Cycle 2 Day 1, Pre-Dose | 0.149 ± 0.128 | 0.395 ± 0.322 |
| Cycle 2 Day 1, 5-minutes Post-Dose | 25.3 ± 7.56 | 32.9 ± 9.80 |
| Cycle 2 Day 2, 24 Hours Post-Dose | 8.80 ± 6.19 | 10.4 ± 8.05 |
| Cycle 2 Day 3, 48 Hours Post-Dose | 3.70 ± 1.95 | 11.4 ± 16.8 |
| Cycle 2 Day 5, 96 Hours Post-Dose | 2.04 ± 1.26 | 9.61 ± 17.9 |
| Cycle 3 Day 1, Pre-Dose | 0.116 ± 0.163 | 0.491 ± 0.387 |
| Cycle 3 Day 1, 5 minutes Post-Dose | 23.9 ± 2.83 | 31.3 ± 9.79 |
| Cycle 4 Day 1, Pre-dose | 0.218 ± 0.271 | 0.691 ± 0.492 |
| Cycle 4 Day 1, 5 minutes Post-Dose | 22.9 ± 4.60 | 30.0 ± 12.2 |
| Cycle 5 Day 1, Pre-Dose | 0.264 ± 0.321 | 0.845 ± 0.564 |
| Cycle 5 Day 1, 5 minutes Post-Dose | 22.5 ± 3.32 | 30.6 ± 15.1 |
| Cycle 6 Day 1, Pre-Dose | 0.312 ± 0.351 | 1.06 ± 0.699 |
| Cycle 6 Day 1, 5 minutes Post-Dose | 20.3 ± 4.38 | 33.2 ± 16.1 |
| Cycle 7 Day 1, Pre-Dose | 0.327 ± 0.337 | 1.04 ± 0.618 |
| Cycle 7 Day 1, 5 minutes Post-Dose | 17.9 ± 2.40 | 32.3 ± 15.4 |
| Cycle 8 Day 1, Pre-Dose | — | 1.25 ± 0.565 |
| Cycle 8 Day 1, 5 minutes Post-Dose | — | 35.2 ± 10.5 |
| Cycle 8 Day 2, 24 Hours Post-Dose | — | 14.0 ± 4.55 |
| Cycle 8 Day 3, 48 Hours Post-Dose | — | 9.53 ± 2.96 |
| Cycle 8 Day 5, 96 Hours Post-Dose | — | 6.44 ± 2.35 |
| Cycle 8 Day 14, 312 Hours Post-Dose | — | 3.30 ± 4.63 |
| Cycle 9 Day 1, Pre-Dose | — | 4.37 ± 11.7 |
| Cycle 9 Day 1, 5 Minutes Post-Dose | — | 29.6 ± 11.3 |
| Cycle 10 Day 1, Pre-Dose | — | 1.20 ± 0.455 |
| Cycle 10 Day 1, 5 minutes Post-Dose | — | 35.7 ± 9.50 |
| Cycle 11 Day 1, Pre-Dose | — | 1.84 ± 1.57 |
| Cycle 11 Day 1, 5 minutes Post-Dose | — | 35.7 ± 10.8 |
| Cycle 12 Day 1, Pre-Dose | — | 1.47 ± 0.665 |
| Cycle 12 Day 1, 5 minutes Post-Dose | — | 40.0 ± 10.4 |
| Cycle 13 Day 1, Pre-Dose | — | 6.28 ± 11.5 |
| Cycle 13 Day 1, 5 minutes Post-Dose | — | 33.3 ± 16.1 |
| Cycle 14 Day 1, Pre-Dose | — | 1.60 ± 0.600 |
| Cycle 14 Day 1, 5 minutes Post-Dose | — | 37.0 ± 7.92 |
| Cycle 15 Day 1, Pre-Dose | — | 1.48 ± 0.542 |
| Cycle 15 Day 1, 5 minutes Post-Dose | — | 40.3 ± 10.6 |
| Cycle 16 Day 1, Pre-Dose | — | 1.52 ± 0.361 |
| Cycle 16 Day 1, 5 minutes Post-Dose | — | 41.5 ± 4.70 |
Blood samples were collected and tested for conjugated and unconjugated antibodies.
| ug/mL | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| Cycle 1 Day 1, Pre-Dose | NA ± NA | NA ± NA |
| Cycle 1 Day 1, 5 Minutes Post-Dose | 26.3 ± 2.29 | 34.7 ± 13.4 |
| Cycle 1 Day 2, 24 Hours Post-Dose | 16.7 ± 1.50 | 25.0 ± 9.59 |
| Cycle 1 Day 3, 48 Hours Post-Dose | 12.7 ± 3.13 | 18.5 ± 7.57 |
| Cycle 1 Day 5, 96 Hours Post-Dose | 8.63 ± 5.11 | 11.8 ± 5.02 |
| Cycle 1 Day 14, 312 Hours Post-Dose | 2.23 ± 0.833 | 3.50 ± 1.70 |
| Cycle 2 Day 1, Pre-Dose | 0.470 ± 0.459 | 1.16 ± 0.825 |
| Cycle 2 Day 1, 5-minutes Post-Dose | 26.9 ± 7.98 | 35.6 ± 12.0 |
| Cycle 2 Day 2, 24 Hours Post-Dose | 17.1 ± 10.4 | 17.2 ± 7.93 |
| Cycle 2 Day 3, 48 Hours Post-Dose | 9.60 ± 5.39 | 16.0 ± 6.73 |
| Cycle 2 Day 3, 96 Hours Post-Dose | 6.43 ± 3.69 | 10.2 ± 5.16 |
| Cycle 3 Day 1, Pre-Dose | 0.415 ± 0.586 | 1.62 ± 1.07 |
| Cycle 3 Day 1, 5 minutes Post-Dose | 30.0 ± 5.87 | 38.2 ± 13.1 |
| Cycle 4 Day 1, Pre-dose | 0.875 ± 1.03 | 1.95 ± 1.26 |
| Cycle 4 Day 1, 5 minutes Post-Dose | 29.6 ± 8.13 | 37.1 ± 15.6 |
| Cycle 5 Day 1, Pre-Dose | 0.844 ± 0.928 | 2.45 ± 1.68 |
| Cycle 5 Day 1, 5 minutes Post-Dose | 29.4 ± 3.04 | 38.0 ± 18.8 |
| Cycle 6 Day 1, Pre-Dose | 1.05 ± 1.20 | 2.99 ± 1.81 |
| Cycle 6 Day 1, 5 minutes Post-Dose | 29.4 ± 5.37 | 39.8 ± 19.8 |
| Cycle 7 Day 1, Pre-Dose | 0.995 ± 0.998 | 2.92 ± 1.62 |
| Cycle 7 Day 1, 5 minutes Post-Dose | 24.0 ± 2.69 | 41.0 ± 21.2 |
| Cycle 8 Day 1, Pre-Dose | — | 3.29 ± 1.14 |
| Cycle 8 Day 1, 5 minutes Post-Dose | — | 41.4 ± 9.47 |
| Cycle 8 Day 2, 24 Hours Post-Dose | — | 28.2 ± 6.38 |
| Cycle 8 Day 3, 48 Hours Post-Dose | — | 22.9 ± 5.67 |
| Cycle 8 Day 5, 96 Hours Post-Dose | — | 17.3 ± 4.93 |
| Cycle 8 Day 14, 312 Hours Post-Dose | — | 5.74 ± 2.02 |
| Cycle 9 Day 1, Pre-Dose | — | 6.30 ± 12.0 |
| Cycle 9 Day 1, 5 Minutes Post-Dose | — | 35.1 ± 11.3 |
| Cycle 10 Day 1, Pre-Dose | — | 3.48 ± 1.13 |
| Cycle 10 Day 1, 5 minutes Post-Dose | — | 41.4 ± 8.63 |
| Cycle 11 Day 1, Pre-Dose | — | 3.96 ± 2.24 |
| Cycle 11 Day 1, 5 minutes Post-Dose | — | 42.8 ± 8.85 |
| Cycle 12 Day 1, Pre-Dose | — | 3.47 ± 1.28 |
| Cycle 12 Day 1, 5 minutes Post-Dose | — | 44.8 ± 10.3 |
| Cycle 13 Day 1, Pre-Dose | — | 11.3 ± 17.1 |
| Cycle 13 Day 1, 5 minutes Post-Dose | NA ± NA | 40.3 ± 19.2 |
| Cycle 14 Day 1, Pre-Dose | — | 3.97 ± 1.14 |
| Cycle 14 Day 1, 5 minutes Post-Dose | — | 44.5 ± 7.05 |
| Cycle 15 Day 1, Pre-Dose | — | 4.02 ± 1.40 |
| Cycle 15 Day 1, 5 minutes Post-Dose | — | 49.7 ± 6.88 |
| Cycle 16 Day 1, Pre-Dose | — | 4.60 ± 1.67 |
| Cycle 16 Day 1, 5 minutes Post-Dose | — | 49.7 ± 7.61 |
Blood samples were collected and tested for MMAE plasma concentrations.
| ng/mL | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 |
|---|---|---|
| Cycle 1 Day 1, Pre-Dose | NA ± NA | NA ± NA |
| Cycle 1 Day 1, 5 Minutes Post-Dose | 0.416 ± 0.480 | 0.368 ± 0.309 |
| Cycle 1 Day 2, 24 Hours Post-Dose | 4.63 ± 3.20 | 4.88 ± 3.55 |
| Cycle 1 Day 3, 48 Hours Post-Dose | 4.20 ± 1.95 | 5.36 ± 3.72 |
| Cycle 1 Day 5, 96 Hours Post-Dose | 2.80 ± 0.300 | 4.43 ± 3.04 |
| Cycle 1 Day 14, 312 Hours Post-Dose | 0.196 ± 0.0641 | 0.530 ± 0.552 |
| Cycle 2 Day 1, Pre-Dose | 0.0647 ± 0.0358 | 0.0739 ± 0.0640 |
| Cycle 2 Day 1, 5-minutes Post-Dose | 0.556 ± 0.562 | 0.478 ± 0.461 |
| Cycle 2 Day 2, 24 Hours Post-Dose | 5.63 ± 5.72 | 3.71 ± 3.94 |
| Cycle 2 Day 3, 48 Hours Post-Dose | 4.60 ± 3.70 | 3.86 ± 3.18 |
| Cycle 2 Day 5, 96 Hours Post-Dose | 2.60 ± 1.04 | 2.70 ± 1.69 |
| Cycle 3 Day 1, Pre-Dose | 0.0250 ± 0.0354 | 0.0650 ± 0.0590 |
| Cycle 3 Day 1, 5 minutes Post-Dose | 0.216 ± 0.0361 | 0.514 ± 0.684 |
| Cycle 4 Day 1, Pre-dose | 0.0565 ± 0.00495 | 0.0866 ± 0.0784 |
| Cycle 4 Day 1, 5 minutes Post-Dose | 0.234 ± 0.0742 | 0.376 ± 0.449 |
| Cycle 5 Day 1, Pre-Dose | 0.0820 ± NA | 0.0862 ± 0.0729 |
| Cycle 5 Day 1, 5 minutes Post-Dose | 0.334 ± 0.0955 | 0.301 ± 0.248 |
| Cycle 6 Day 1, Pre-Dose | 0.0680 ± 0.0156 | 0.0841 ± 0.0632 |
| Cycle 6 Day 1, 5 minutes Post-Dose | 0.247 ± 0.00707 | 0.450 ± 0.663 |
| Cycle 7 Day 1, Pre-Dose | 0.104 ± 0.0389 | 0.0830 ± 0.0578 |
| Cycle 7 Day 1, 5 minutes Post-Dose | 0.326 ± 0.0361 | 0.310 ± 0.282 |
| Cycle 8 Day 1, Pre-Dose | — | 0.101 ± 0.934 |
| Cycle 8 Day 1, 5 minutes Post-Dose | — | 0.295 ± 0.151 |
| Cycle 8 Day 2, 24 Hours Post-Dose | — | 1.96 ± 1.31 |
| Cycle 8 Day 3, 48 Hours Post-Dose | — | 1.91 ± 1.29 |
| Cycle 8 Day 5, 96 Hours Post-Dose | — | 2.00 ± 1.05 |
| Cycle 8 Day 14, 312 Hours Post-Dose | — | 0.325 ± 0.214 |
| Cycle 9 Day 1, Pre-Dose | — | 0.0819 ± 0.0496 |
| Cycle 9 Day 1, 5 Minutes Post-Dose | — | 0.218 ± 0.128 |
| Cycle 10 Day 1, Pre-Dose | — | 0.727 ± 0.0517 |
| Cycle 10 Day 1, 5 minutes Post-Dose | — | 0.204 ± 0.0982 |
| Cycle 11 Day 1, Pre-Dose | — | 0.0763 ± 0.0368 |
| Cycle 11 Day 1, 5 minutes Post-Dose | — | 0.255 ± 0.133 |
| Cycle 12 Day 1, Pre-Dose | — | 0.105 ± 0.0983 |
| Cycle 12 Day 1, 5 minutes Post-Dose | — | 0.252 ± 0.116 |
| Cycle 13 Day 1, Pre-Dose | — | 0.110 ± 0.0629 |
| Cycle 13 Day 1, 5 minutes Post-Dose | — | 0.244 ± 0.130 |
| Cycle 14 Day 1, Pre-Dose | — | 0.109 ± 0.0529 |
| Cycle 14 Day 1, 5 minutes Post-Dose | — | 0.320 ± 0.138 |
| Cycle 15 Day 1, Pre-Dose | — | 0.0843 ± 0.0548 |
| Cycle 15 Day 1, 5 minutes Post-Dose | — | 0.404 ± 0.192 |
| Cycle 16 Day 1, Pre-Dose | — | 0.139 ± 0.0926 |
| Cycle 16 Day 1, 5 minutes Post-Dose | — | 0.381 ± 0.277 |
Collected over From the first dose through 30 days after the last dose of study medication (Up to 15 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 1/3 (33.3%) | 0/3 (0%) | 3/3 (100%) |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 6/16 (37.5%) | 7/16 (43.8%) | 16/16 (100%) |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 2/17 (11.8%) | 1/17 (5.9%) | 17/17 (100%) |
| Event | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| HepatotoxicityHepatobiliary disorders | 0/3 | 1/16 | 0/17 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/3 | 1/16 | 0/17 |
| PneumoniaInfections and infestations | 0/3 | 1/16 | 0/17 |
| PyrexiaGeneral disorders | 0/3 | 1/16 | 1/17 |
| VomitingGastrointestinal disorders | 0/3 | 1/16 | 0/17 |
| Anaphylactic reactionImmune system disorders | 0/3 | 1/16 | 0/17 |
| Supraventricular tachycardiaCardiac disorders | 0/3 | 1/16 | 0/17 |
| Cardiac arrestCardiac disorders | 0/3 | 1/16 | 0/17 |
| MyalgiaGeneral disorders | 0/3 | 1/16 | 0/17 |
| Event | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only |
|---|---|---|---|
| NauseaGastrointestinal disorders | 2/3 | 7/16 | 4/17 |
| PyrexiaGeneral disorders | 1/3 | 8/16 | 7/17 |
| Abdominal pain upperGastrointestinal disorders | 1/3 | 2/16 | 1/17 |
| Abdominal painGastrointestinal disorders | 1/3 | 2/16 | 0/17 |
| Upper respiratory tract infectionInfections and infestations | 1/3 | 0/16 | 0/17 |
| ParaesthesiaNervous system disorders | 1/3 | 5/16 | 1/17 |
| DysgeusiaNervous system disorders | 1/3 | 0/16 | 0/17 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/3 | 1/16 | 0/17 |
| Drug eruptionSkin and subcutaneous tissue disorders | 1/3 | 0/16 | 0/17 |
| Lymphocyte count decreasedInvestigations | 1/3 | 0/16 | 2/17 |
Safety population is defined as participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| Mean | 14.7 ± 1.15 | 14.5 ± 2.68 | 11.5 ± 3.18 | 13.1 ± 3.19 |
| Sex: Female, Male(Participants) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| Female | 1 | 7 | 3 | 11 |
| Male | 2 | 9 | 14 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 4 | 4 |
| Not Hispanic or Latino | 3 | 14 | 12 | 29 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| White | 2 | 13 | 16 | 31 |
| Asian | 1 | 0 | 1 | 2 |
| Other | 0 | 2 | 0 | 2 |
| Not Reported | 0 | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| United States | 2 | 1 | 1 | 4 |
| France | 0 | 2 | 0 | 2 |
| Germany | 0 | 4 | 1 | 5 |
| Netherlands | 0 | 1 | 2 | 3 |
| United Kingdom | 0 | 1 | 2 | 3 |
| Italy | 1 | 7 | 6 | 14 |
| Spain | 0 | 0 | 4 | 4 |
| Mexico | 0 | 0 | 1 | 1 |
| Height(cm) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| Mean | 167.17 ± 10.865 | 165.31 ± 14.350 | 149.54 ± 17.783 | 158.02 ± 17.493 |
| Weight(kg) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| Mean | 53.10 ± 9.924 | 57.85 ± 17.539 | 42.16 ± 15.162 | 50.04 ± 17.361 |
| Body Surface Area(m^2) | Brentuximab Vedotin 1.4 mg/kg: Phase 1 | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | Total |
|---|---|---|---|---|
| Mean | 1.562 ± 0.0967 | 1.617 ± 0.2938 | 1.313 ± 0.3103 | 1.469 ± 0.3228 |
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 Apr 2012 to primary completion in Oct 2016, 53 months.
Results were first posted in May 2017, 7 months after primary completion. A results delay was requested in Feb 2017.
Of 63 phase 1/2 interventional studies under Hodgkin Disease, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 53 and three quarters within 97. This study's 53 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brentuximab Vedotin
Millennium Pharmaceuticals, Inc. →