RecruitingPhase 2NCT06792825

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

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

65 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma Marginal Zone Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — tafasitamab, lenalidomide, and rituximab — in people newly diagnosed with certain slow-growing lymphomas: follicular lymphoma or marginal zone lymphoma. These are cancers of the lymph nodes and immune system. **You may be eligible if...** - You have confirmed follicular lymphoma (Grade 1, 2, or 3a) or marginal zone lymphoma - You have not yet received any treatment for your lymphoma - Your disease is causing significant symptoms or is affecting vital organs **You may NOT be eligible if...** - You have already received treatment for your lymphoma - Your disease is not yet requiring treatment - You have serious heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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