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Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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)

NCT04404283•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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
+2 more criteria

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

Key Dates

Start Date

August 20, 2020

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

March 17, 2026

Enrollment

238

ACTUAL participants

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Brentuximab vedotin

DRUG

Rituximab

DRUG

Lenalidomide

DRUG

Placebo

OTHER

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

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RECRUITINGPHASE3

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Long-term Follow up Local Registry Study of Kymriah in South Korea

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms