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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT06792825
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 7, 2025
Status verified
Aug 2025
Primary completion
Jul 8, 2029
Completion
Jul 8, 2031

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Follicular Lymphoma
    On Cycle 1, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on Day 1, Day 8, Day 15 and Day 22, and lenalidomide 20 mg PO Day 1 through Day 21. On Cycles 2-3, patients will receive tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on day 1, and lenalidomide 20 mg PO Day 1-21. On Cycles 4-6, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Rituximab 375 mg/m2 IV on Day 1, and lenalidomide 20 mg PO from Day 1-21. At the end of Cycle 6, patients on both cohorts will be assessed by Lugano standard. Patients in complete remission (CR) will continue on tafasitamab/rituximab and discontinue lenalidomide. Patients with partial response (PR) or stable disease (SD) will continue on all three drugs, tafasitamab/rituximab/lenalidomide, and if progressive disease (PD) will discontinue study.
  • Experimental: Marginal Zone Lymphoma
    On Cycle 1, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on Day 1, Day 8, Day 15 and Day 22, and lenalidomide 20 mg PO Day 1 through Day 21. On Cycles 2-3, patients will receive tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22, rituximab 375 mg/m2 IV on day 1, and lenalidomide 20 mg PO Day 1-21. On Cycles 4-6, patients will receive an infusion of tafasitamab 12 mg/kg IV on Day 1, Rituximab 375 mg/m2 IV on Day 1, and lenalidomide 20 mg PO from Day 1-21. At the end of Cycle 6, patients on both cohorts will be assessed by Lugano standard. Patients in complete remission (CR) will continue on tafasitamab/rituximab and discontinue lenalidomide. Patients with partial response (PR) or stable disease (SD) will continue on all three drugs, tafasitamab/rituximab/lenalidomide, and if progressive disease (PD) will discontinue study.

Primary Outcome Measure

Complete response (CR) [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer CenterMinneapolisMinnesota55455
Sanjal Desai, MD
[email protected]
612-624-9452

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By research site
Masonic Cancer Center· Minneapolis, MN

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