Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Study ID
NCT04404283
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab vedotin — DRUG
    1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
  • Rituximab — DRUG
    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 — DRUG
    20 mg given by mouth (orally) daily
  • Placebo — OTHER
    Administered via intravenous infusion every 3 weeks

Study Details

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.

Key Dates

Start date
Aug 20, 2020
Status verified
Apr 2026
Primary completion
Jan 12, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
239 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Brentuximab vedotin + lenalidomide + rituximab
  • Active Comparator: Control Arm
    Placebo + lenalidomide + rituximab

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Approximately 2 years ]

Locations (49)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35209-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California Davis Medical CenterSacramentoCalifornia95817-
Florida Cancer SpecialistsBonita SpringsFlorida34135-
Florida Cancer SpecialistsBradentonFlorida34211-
Florida Cancer SpecialistsCape CoralFlorida33909-
Florida Cancer SpecialistsDaytona BeachFlorida32117-
Florida Cancer SpecialistsFort MyersFlorida33905-
Florida Cancer SpecialistsFort MyersFlorida33908-
Florida Cancer SpecialistsNaplesFlorida34102-
Florida Cancer SpecialistsPort CharlotteFlorida33980-
Florida Cancer SpecialistsSarasotaFlorida34232-
Florida Cancer SpecialistsSarasotaFlorida34236-
Florida Cancer SpecialistsStuartFlorida34994-
Florida Cancer SpecialistsVeniceFlorida34285-
Florida Cancer SpecialistsVeniceFlorida34292-
Florida Cancer SpecialistsVero BeachFlorida32960-
Florida Cancer SpecialistsWellingtonFlorida33414-
Florida Cancer SpecialistsWest Palm BeachFlorida33401-
MidAmerica Division, Inc. c/o Menorah Medical CenterOverland ParkKansas66209-
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Henry Ford HospitalDetroitMichigan48202-
Karmanos Cancer InstituteDetroitMichigan48201-
Karmanos Cancer Institute Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Henry Ford Medical Center - ColumbusNoviMichigan48377-
Siteman Cancer Center - St. PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
MidAmerica Division, Inc. c/o Centerpoint Medical CenterIndependenceMissouri64057-
MidAmerica Division, Inc., c/o Research Medical CenterKansas CityMissouri64132-
Barnes Jewish-HospitalSt LouisMissouri63110-
Siteman Cancer Center - North CountySt LouisMissouri63136-
Siteman Cancer Center - South CountySt LouisMissouri63129-
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110-
Oncology_Hematology Care Clinical Trials,LLCCincinnatiOhio45211-
Oncology_Hematology Care Clinical Trials,LLCCincinnatiOhio45236-
Oncology_Hematology Care Clinical Trials,LLCCincinnatiOhio45242-
Oncology_Hematology Care Clinical Trials,LLCCincinnatiOhio45245-
University of Cincinnati Medical CenterCincinnatiOhio45219-
University of Cincinnati Medical Center IDS PharmacyCincinnatiOhio45219-
Oncology_Hematology Care Clinical Trials,LLCFairfieldOhio45014-
West Chester HospitalWest ChesterOhio45069-
Oncology Associates of Oregon, P.C.EugeneOregon97401-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Roper St. Francis HealthcareCharlestonSouth Carolina29414-
Roper St. Francis HealthcareMt. PleasantSouth Carolina29464-
Roper St. Francis HealthcareNorth CharlestonSouth Carolina29406-
US Oncology Investigational Products CenterIrvingTexas75063-
University of Virginia Cancer Center.CharlottesvilleVirginia22903-
University of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Birmingham, AL

By research site
Central Alabama Research· Birmingham, ALUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of California Davis Medical Center· Sacramento, CAFlorida Cancer Specialists· Bonita Springs, FLFlorida Cancer Specialists· Bradenton, FLFlorida Cancer Specialists· Cape Coral, FL

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