NCT06792825 HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
| NCT ID | NCT06792825 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2029-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 65 participants in total. It began in 2025-08-07 with a primary completion date of 2029-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06792825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Follicular Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06792825 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06792825 currently recruiting?
Yes, NCT06792825 is actively recruiting participants. Contact the research team at desai171@umn.edu for enrollment information.
Where is the NCT06792825 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06792825 clinical trial?
NCT06792825 is sponsored by Masonic Cancer Center, University of Minnesota. The trial plans to enroll 65 participants.