At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 329 enrolled
Drug / intervention
brentuximab vedotin +1 moredrug
Likely dose
brentuximab vedotin 1.8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
In Brief
A Phase 3 clinical trial evaluating brentuximab vedotin and placebo for Disease, Hodgkin. Completed, enrolled 329 participants across 87 sites in 13 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDisease, Hodgkin
CountriesBulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, United Kingdom, United States
CollaboratorsMillennium Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartApr 2010
Primary CompletionAug 2014
Study CompletionApr 2020
TodayJul 2026
First PostedApr 9, 2010
Enrollment StartApr 30, 2010
Primary CompletionAug 31, 2014
Study CompletionApr 27, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.2 years ago
Interventions
brentuximab vedotindrug
Every 21 days by IV infusion (1.8 mg/kg)
placebodrug
Every 21 days by IV infusion