Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-23; most recent amendment 2025-08-07.
Status change: Not Yet Recruiting → Recruiting 2025-08-07
Trial Details
NCT Number NCT06792825
Lead Sponsor Masonic Cancer Center, University of Minnesota
Collaborators: Incyte Corporation
Conditions Follicular Lymphoma, Marginal Zone Lymphoma
Enrollment 65 participants
Start Date 2025-08-07
Primary Completion 2029-07-08 (estimated)
Study Completion 2031-07-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-12