NCT06792825

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Tafasitamab	Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.
DRUG	Rituximab	Rituximab 375 mg/m2 IV on day 1
DRUG	Lenalidomide	Lenalidomide 20 mg PO Day 1 through Day 21

Timeline

• Start date: 2025-08-07
• Primary completion: 2029-07-08
• Completion: 2031-07-08
• First posted: 2025-01-27
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study