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ACTIVE NOT RECRUITING

NCT04404283

PHASE3

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

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2020-08-20

Completion Date

2026-12-31

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Diffuse Large B-cell Lymphoma

Interventions

DRUG

Brentuximab vedotin

1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks

DRUG

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.

DRUG

Lenalidomide

20 mg given by mouth (orally) daily

OTHER

Placebo

Administered via intravenous infusion every 3 weeks

Inclusion Criteria: * Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically determined by local pathology assessment for the purposes of study eligibility and stratification. * Participants must have R/R disease following 2 or more lines of prior systemic therapy. * For participants with transformed DLBCL, at least the last systemic therapy used must have been for DLBCL * Participants must be HSCT or CAR-T ineligible according to the investigator and must meet at least one of the following criteria: 1. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic dysfunction that in the opinion of the Investigator make the participant medically unfit to received HSCT or CAR-T therapy 2. Active disease following induction and salvage chemotherapy 3. Inadequate stem cell mobilization (for HSCT) 4. Relapse following prior HSCT or CAR-T 5. Unable to receive CAR-T therapy due to financial, geographic, insurance, or manufacturing issues * Participants must have tumor tissue submitted to the central pathology lab. The tumor tissue submitted should be from the most recent biopsy that contains DLBCL. * An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist within 28 days of Day 1. Exclusion Criteria: * History of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy * History of progressive multifocal leukoencephalopathy (PML) * Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months. * Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted * Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment * Previous treatment with brentuximab vedotin or lenalidomide. * Previous treatment with other vedotin-based ADCs is permitted if the last dose is at least 6 months prior to Day 1. * Current therapy with immunosuppressive medications (including steroids), other systemic anti-neoplastic, or investigational agents a) Prednisone (or equivalent) ≤10 mg/day may be used for non-lymphomatous purposes * Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study drugs * Congestive heart failure, Class III or IV, by the NYHA criteria * Grade 2 or higher peripheral sensory or motor neuropathy at baseline

Locations (171)

Central Alabama Research

Birmingham, Alabama, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Florida Cancer Specialists

Bonita Springs, Florida, United States

Florida Cancer Specialists

Bradenton, Florida, United States

Florida Cancer Specialists

Cape Coral, Florida, United States

Florida Cancer Specialists

Daytona Beach, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists

Naples, Florida, United States

Florida Cancer Specialists

Port Charlotte, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Florida Cancer Specialists

Stuart, Florida, United States

Florida Cancer Specialists

Venice, Florida, United States

Florida Cancer Specialists

Venice, Florida, United States

Florida Cancer Specialists

Vero Beach, Florida, United States

Florida Cancer Specialists

Wellington, Florida, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

MidAmerica Division, Inc. c/o Menorah Medical Center

Overland Park, Kansas, United States

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

IP ADDRESS: Brigitte Harris Cancer Pavilion (BHCP)

Detroit, Michigan, United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, United States

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

MidAmerica Division, Inc. c/o Centerpoint Medical Center

Independence, Missouri, United States

MidAmerica Division, Inc., c/o Research Medical Center

Kansas City, Missouri, United States

Barnes Jewish-Hospital

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Siteman Cancer Center - South County

St Louis, Missouri, United States

Siteman Cancer Center - North County

St Louis, Missouri, United States

Oncology_Hematology Care Clinical Trials,LLC