HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL (NCT06792825) | Clinical Trial Compass
RecruitingPhase 2
HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
United States65 participantsStarted 2025-08-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete response (CR)
Timeframe: 1 year
Trial details
NCT IDNCT06792825
SponsorMasonic Cancer Center, University of Minnesota