drugset / Trial / NCT06792825
HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
Phase 2
Recruiting
65 enrolled
Masonic Cancer Center, University of Minnesota
Incyte Corporation · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-07
- Primary completion
- 2029-07-08
- Completion
- 2031-07-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Tafasitamab | Monoclonal antibody | 12 mg/kg | Intravenous |