HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 than 10% within the prior 6 months

• Any other symptoms attributable to lymphomatous mass

• Endangerment of vital organ due to lymphomatous mass including but not limited to:

• Symptomatic or massive splenomegaly

• Compression syndrome (including but not limited to ureteral, orbital, gastrointestinal)

• Pleural, pericardial or ascitic effusion regardless of cell count

• Follicular lymphoma in leukemic phase (\>5 X 109/L circulating cells)

⁃ OR:

• Follicular lymphoma graded high-risk by FLIPI2 score (see Appendix III)

• Adequate organ function within 14 days (28 days for pulmonary or cardiac) of study registration

• Participants who are of childbearing potential or have partners of child-bearing potential must agree to either total abstinence or use of both a highly effective (IUD, hormonal contraceptives, tubal ligation or vasectomy), and effective contraception (male or female condom, diaphragm or cervical cap) for the duration of treatment and for 12 months after the last dose of study drug.

• Able to tolerate prophylactic anticoagulation/antiplatelet therapy while on lenalidomide

• Able to provide written voluntary consent prior to the performance of any research related tests or procedures (or the subject's legally authorized representative (LAR) if enrollment of persons with diminished capacity is permitted - general permitted for Phase II and greater studies)

Locations
United States
Minnesota
Masonic Cancer Center
RECRUITING
Minneapolis
Contact Information
Primary
Sanjal Desai, MD
desai171@umn.edu
612-624-9452
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2031-07-08
Participants
Target number of participants: 65
Treatments
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.
Sponsors
Leads: Masonic Cancer Center, University of Minnesota
Collaborators: Incyte Corporation

This content was sourced from clinicaltrials.gov