A Phase 3 interventional study of brentuximab vedotin and placebo in Disease, Hodgkin, sponsored by Seagen Inc.. Completed at 87 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by Seagen Inc. · Phase 3, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 329 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Drug: brentuximab vedotin
placebo every 3 weeks by IV infusion
Drug: placebo
Every 21 days by IV infusion (1.8 mg/kg)
Also known as: SGN-35, Adcetris
Every 21 days by IV infusion
Progression-free Survival by Independent Review
Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
Time frame: Up to approximately 4 years
Overall Survival
Time from date of randomization to date of death due to any cause
Time frame: Up to approximately 10 years
Incidence of Adverse Events or Laboratory Abnormalities
Time frame: Up to 12 months
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Time frame: Up to 12 months
Apr 2010-Aug 2014
| Milestone | Brentuximab Vedotin | Placebo |
|---|---|---|
| Started | 165 | 164 |
| Completed | 89 | 70 |
| Not completed | 76 | 94 |
| Withdrew: Withdrawal by subject | 18 | 25 |
| Withdrew: Lost to follow-up | 13 | 28 |
| Withdrew: Site request to end participation in study | 0 | 1 |
| Withdrew: Death | 45 | 40 |
Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
| months | Brentuximab Vedotin | Placebo |
|---|---|---|
| Progression-free Survival by Independent Review | 42.9 (30.4 to 42.9) | 24.1 (11.5 to NA) |
Time from date of randomization to date of death due to any cause
| months | Brentuximab Vedotin | Placebo |
|---|---|---|
| Overall Survival | NA (1.31 to 117.88) | NA (0.03 to 119.23) |
| participants | Brentuximab Vedotin | Placebo |
|---|---|---|
| Any Treatment-Emergent Adverse Event | 163 | 142 |
| Any Treatment-Related Adverse Event | 147 | 79 |
| Any Adverse Event with Severity >= Grade 3 | 93 | 51 |
| Any Serious Adverse Event | 41 | 20 |
| Any Treatment-Related Serious Adverse Events | 19 | 7 |
| Treatment Discontinuation Due to Adverse Event | 54 | 10 |
| Any Laboratory Abnormalities Severity >=Grade 3 | 69 | 29 |
| participants | Brentuximab Vedotin | Placebo |
|---|---|---|
| Baseline Negative | 138 | 142 |
| Baseline Negative: -'ve Postbaseline | 92 | 104 |
| Baseline Negative: Transiently +'ve Postbaseline | 36 | 27 |
| Baseline Negative: Persistently +'ve Postbaseline | 10 | 11 |
| Baseline Positive | 19 | 12 |
| Baseline Positive: -'ve Postbaseline | 7 | 0 |
| Baseline Positive: Transiently +'ve Postbaseline | 9 | 5 |
| Baseline Positive: Persistently +'ve Postbaseline | 3 | 7 |
Collected over Non-serious adverse events were followed for up to 15 months. Serious adverse event data were collected for up to approximately 10 years (116 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 40/160 (25%) | 21/160 (13.1%) | 127/160 (79.4%) |
| Brentuximab Vedotin | 45/167 (26.9%) | 43/167 (25.7%) | 151/167 (90.4%) |
| Event | Placebo | Brentuximab Vedotin |
|---|---|---|
| PneumoniaInfections and infestations | 4/160 | 7/167 |
| PyrexiaGeneral disorders | 2/160 | 6/167 |
| VomitingGastrointestinal disorders | 1/160 | 5/167 |
| NauseaGastrointestinal disorders | 1/160 | 4/167 |
| HepatotoxicityHepatobiliary disorders | 1/160 | 3/167 |
| Peripheral sensory neuropathyNervous system disorders | 0/160 | 3/167 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/160 | 0/167 |
| ConstipationGastrointestinal disorders | 0/160 | 2/167 |
| Herpes zosterInfections and infestations | 1/160 | 2/167 |
| HeadacheNervous system disorders | 0/160 | 2/167 |
| Event | Placebo | Brentuximab Vedotin |
|---|---|---|
| Peripheral sensory neuropathyNervous system disorders | 25/160 | 92/167 |
| NeutropeniaBlood and lymphatic system disorders | 18/160 | 58/167 |
| Upper respiratory tract infectionInfections and infestations | 37/160 | 43/167 |
| FatigueGeneral disorders | 29/160 | 40/167 |
| Peripheral motor neuropathyNervous system disorders | 3/160 | 37/167 |
| CoughRespiratory, thoracic and mediastinal disorders | 26/160 | 35/167 |
| NauseaGastrointestinal disorders | 12/160 | 34/167 |
| DiarrhoeaGastrointestinal disorders | 15/160 | 33/167 |
| Weight decreasedInvestigations | 9/160 | 31/167 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 15/160 | 30/167 |
Intention-to-Treat analysis set
| Age, Continuous(years) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| Median | 33 (18 to 71) | 32 (18 to 76) | 32 (18 to 76) |
| Sex: Female, Male(Participants) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| Female | 89 | 67 | 156 |
| Male | 76 | 97 | 173 |
| Race (NIH/OMB)(Participants) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 2 | 12 |
| White | 153 | 156 | 309 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Region of Enrollment(Participants) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| Russian Federation | 20 | 19 | 39 |
| Romania | 4 | 6 | 10 |
| Hungary | 9 | 11 | 20 |
| United States | 67 | 68 | 135 |
| United Kingdom | 3 | 3 | 6 |
| Spain | 4 | 6 | 10 |
| Czech Republic | 5 | 0 | 5 |
| Poland | 26 | 28 | 54 |
| Italy | 9 | 7 | 16 |
| France | 8 | 5 | 13 |
| Serbia | 3 | 6 | 9 |
| Bulgaria | 7 | 2 | 9 |
| Germany | 0 | 3 | 3 |
| Eastern Cooperative Oncology Group Performance Status(Participants) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| 0 | 87 | 97 | 184 |
| 1 | 77 | 67 | 144 |
| 2 | 1 | 0 | 1 |
| Hodgkin Lymphoma Status after end of Frontline Therapy(Participants) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| Refractory | 99 | 97 | 196 |
| Relapse in less than 12 months | 53 | 54 | 107 |
| Relapse 12 months or later with extranodal disease | 13 | 13 | 26 |
| Best Response to Salvage Therapy pre-ASCT(Participants) | Brentuximab Vedotin | Placebo | Total |
|---|---|---|---|
| Complete remission | 61 | 62 | 123 |
| Partial remission | 57 | 56 | 113 |
| Stable disease | 47 | 46 | 93 |
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seagen Inc.