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RECRUITINGPHASE2

HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL

HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

NCT06792825•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed marginal zone lymphoma
•Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a
•No prior systemic therapy for lymphoma
•Must be in need of treatment as evidenced by one or more of the following criteria:
•Bulky disease defined as:
•a nodal or extranodal (except spleen) mass \>7cm in its greater diameter or,
•involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \>3 cm)
•Presence of at least one of the following B symptoms:
•fever (\>38C) of unclear etiology
•night sweats
+13 more criteria

Exclusion Criteria

•Seropositive for or active viral infection with hepatitis B virus (HBV):
•HBV surface antigen (HBsAg) positive
•HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA
•Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).
•Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
•Prior history of lenalidomide use
•Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
•Peripheral neuropathy ≥ grade 2 at time of screening
•Uncontrolled intercurrent illness.
•Active infection (requiring systemic therapy) or has received a live vaccine within 14 days prior to first dose of study drug.
+5 more criteria

Locations (1)

Masonic Cancer Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

August 7, 2025

Primary Completion Date

July 8, 2029

Completion Date

July 8, 2031

Last Updated

August 12, 2025

Enrollment

ESTIMATED participants

Conditions

Follicular LymphomaMarginal Zone Lymphoma

Interventions

Tafasitamab

DRUG

Rituximab

DRUG

Lenalidomide

DRUG

Contacts

Sanjal Desai, MD

CONTACT

612-624-9452 desai171@umn.edu

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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: August 12, 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.

View ClinicalTrials.gov Terms and Conditions

HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL

Inclusion Criteria

Exclusion Criteria

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