Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
Condition(s) studied
Investigational drug(s) / intervention(s)
Brentuximab vedotin: 1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
Rituximab: 375 mg/m\^2 administered via intravenous infusion on Cycle 1 Day 1. 1400 mg injected under the skin (subcutaneous) permitted every 3 weeks from Cycle 2 Day 1 through end of treatment.
Lenalidomide: 20 mg given by mouth (orally) daily
Placebo: Administered via intravenous infusion every 3 weeks
Study summary
Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone.
Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — From the date of randomization until date of death or censoring date, whichever occurred first (maximum up to 50 months)
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who had not died were censored at the last known alive date or the data cutoff date, whichever was earlier. OS was estimated using the Kaplan-Meier method.
Trial sites (143)
| Facility | City | Region | Status |
|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | |
| University of California Davis Medical Center | Sacramento | California | |
| Florida Cancer Specialists | Bonita Springs | Florida | |
| Florida Cancer Specialists | Bradenton | Florida | |
| Florida Cancer Specialists | Cape Coral | Florida | |
| Florida Cancer Specialists | Daytona Beach | Florida | |
| Florida Cancer Specialists | Fort Myers | Florida | |
| Florida Cancer Specialists | Fort Myers | Florida | |
| Florida Cancer Specialists | Naples | Florida | |
| Florida Cancer Specialists | Port Charlotte | Florida | |
| Florida Cancer Specialists | Sarasota | Florida | |
| Florida Cancer Specialists | Sarasota | Florida | |
| Florida Cancer Specialists | Stuart | Florida | |
| Florida Cancer Specialists | Venice | Florida | |
| Florida Cancer Specialists | Venice | Florida | |
| Florida Cancer Specialists | Vero Beach | Florida | |
| Florida Cancer Specialists | Wellington | Florida | |
| Florida Cancer Specialists | West Palm Beach | Florida | |
| MidAmerica Division, Inc. c/o Menorah Medical Center | Overland Park | Kansas | |
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Henry Ford Hospital | Detroit | Michigan | |
| Karmanos Cancer Institute Weisberg Cancer Treatment Center | Farmington Hills | Michigan | |
| Henry Ford Medical Center - Columbus | Novi | Michigan | |
| Siteman Cancer Center - St. Peters | City of Saint Peters | Missouri | |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | |
| MidAmerica Division, Inc. c/o Centerpoint Medical Center | Independence | Missouri | |
| MidAmerica Division, Inc., c/o Research Medical Center | Kansas City | Missouri | |
| Barnes Jewish-Hospital | St Louis | Missouri | |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | |
| Siteman Cancer Center - South County | St Louis | Missouri | |
| Siteman Cancer Center - North County | St Louis | Missouri | |
| Oncology_Hematology Care Clinical Trials,LLC | Cincinnati | Ohio | |
| University of Cincinnati Medical Center | Cincinnati | Ohio | |
| Oncology_Hematology Care Clinical Trials,LLC | Cincinnati | Ohio | |
| Oncology_Hematology Care Clinical Trials,LLC | Cincinnati | Ohio | |
| Oncology_Hematology Care Clinical Trials,LLC | Cincinnati | Ohio | |
| Oncology_Hematology Care Clinical Trials,LLC | Fairfield | Ohio | |
| West Chester Hospital | West Chester | Ohio |
+ 103 more sites — see the full list on the official registry below.
On this site
📄 Adcetris (brentuximab vedotin) drug profile → 📄 Rituxan (rituximab) drug profile → 📄 Revlimid (lenalidomide) drug profile →More Seagen, a wholly owned subsidiary of Pfizer trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04404283 on ClinicalTrials.gov ↗ ← All trials in the UK