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A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

NCT04680052•Incyte Corporation

View on ClinicalTrials.gov

Summary

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
•Willingness to avoid pregnancy or fathering children
•In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
•Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
•Documented relapsed, refractory, or PD after treatment with systemic therapy
•ECOG performance status of 0 to 2

Exclusion Criteria

•Women who are pregnant or breastfeeding.
•Any histology other than FL and MZL or clinical evidence of transformed lymphoma
•Prior non-hematologic malignancy
•Congestive heart failure
•HCV positivity, chronic HBV infection or history of HIV infection
•Active systemic infection
•CNS lymphoma involvement
•Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
•Prior use of lenalidomide in combination with rituximab

Locations (261)

John Muir Health Clinical Research Center

Concord, California, United States

Marin Cancer Care

Greenbrae, California, United States

The Oncology Institute of Hope and Innovation

Pasadena, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Middlesex Hospital Cancer Center

Middletown, Connecticut, United States

Smilow Cancer Hospital

New Haven, Connecticut, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Brcr Medical Center, Inc

Plantation, Florida, United States

Asclepes Research Centers

Weeki Wachee, Florida, United States

Northwest Georgia Oncology Centers,P.C

Marietta, Georgia, United States

Key Dates

Start Date

April 15, 2021

Primary Completion Date

February 23, 2024

Completion Date

August 9, 2028

Last Updated

December 22, 2025

Enrollment

654

ACTUAL participants

Conditions

Follicular LymphomaMarginal Zone Lymphoma

Interventions

tafasitamab

DRUG

rituximab

DRUG

lenalidomide

DRUG

placebo

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

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RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 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: December 22, 2025Data 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.

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A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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