HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma
Masonic Cancer Center, University of Minnesota
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed marginal zone lymphoma * Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a * No prior systemic therapy for lymphoma * Must be in need of treatment as evidenced by one or more of the following criteria: * Bulky disease defined as: * a nodal or extranodal (except spleen) mass \>7cm in its greater diameter or, * involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \>3 cm) * Presence of at least one of the following B symptoms: * fever (\>38C) of unclear etiology * night sweats * weight loss greater…
Interventions
- DrugTafasitamab
Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.
- DrugRituximab
Rituximab 375 mg/m2 IV on day 1
- DrugLenalidomide
Lenalidomide 20 mg PO Day 1 through Day 21
Location
- Masonic Cancer CenterMinneapolis, Minnesota