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

NCT ID: NCT06792825

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-07
• Study Completion Date: 2031-07-08

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tafasitamab

Intervention Type: DRUG

Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.

Rituximab

Intervention Type: DRUG

Rituximab 375 mg/m2 IV on day 1

Lenalidomide

Intervention Type: DRUG

Lenalidomide 20 mg PO Day 1 through Day 21

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.

Group Type: EXPERIMENTAL

Tafasitamab

Intervention Type: DRUG

Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.

Rituximab

Intervention Type: DRUG

Rituximab 375 mg/m2 IV on day 1

Lenalidomide

Intervention Type: DRUG

Lenalidomide 20 mg PO Day 1 through Day 21

Interventions

Tafasitamab

Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.

Intervention Type: DRUG

Rituximab

Rituximab 375 mg/m2 IV on day 1

Intervention Type: DRUG

Lenalidomide

Lenalidomide 20 mg PO Day 1 through Day 21

Intervention Type: DRUG

Other Intervention Names

R2

Eligibility Criteria

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 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)

Exclusion Criteria

• Seropositive for or active viral infection with hepatitis B virus (HBV):
• HBV surface antigen (HBsAg) positive
• HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA
• Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
• Prior history of lenalidomide use
• Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
• Peripheral neuropathy ≥ grade 2 at time of screening
• Uncontrolled intercurrent illness.
• Active infection (requiring systemic therapy) or has received a live vaccine within 14 days prior to first dose of study drug.
• Presence or history of CNS involvement by lymphoma
• Patients who are not willing to take venous thromboembolic (VTE) prophylaxis or antiplatelet therapy
• Recent ( <1 year ) arterial thrombosis (any) or venous thrombosis ≥ grade 3 by CTCAE 5.0.
• Pregnant or breastfeeding as agents used in this study are Pregnancy Category X.

Women of childbearing potential must have two negative pregnancy tests (serum or urine) prior to their first dose of lenalidomide, and must agree to scheduled pregnancy testing while on treatment regardless of their birth control choice, per the requirements of the lenalidomide risk evaluation and mitigation strategy (REMS) program.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sanjal Desai, MD

Role: CONTACT

desai171@umn.edu

612-624-9452

Facility Contacts

Sanjal Desai, MD

Role: primary

desai171@umn.edu

612-624-9452

Other Identifiers

2023LS183

Identifier Type: -

Identifier Source: org_study_id