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

StatusRecruiting
PhasePhase 2
Started2025-08-07
View on ClinicalTrials.gov ↗

Amendment history

2026-08-10
Study Status v3
Re-verified, no change to tracked fields
2025-08-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-01→confirmed 2025-08-07
Study sites0→1
2025-07-15
Study Status v1
Start date2025-07-01→2025-10-01
2025-01-23
Original filing
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.
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