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Phase 2 Trial of Tafasitamab, Lenalidomide, and Rituximab for Lymphoma

This study is testing a new combination of medicines for people with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who have not yet received treatment for their cancer. You might be eligible if you have confirmed FL (stages 1, 2, or 3a) or MZL, and your lymphoma needs treatment, for example, if you have a large tumor. The study will look at how well the combination of tafasitamab, lenalidomide (a pill taken daily for 21 days), and rituximab (given intravenously, meaning through a vein) works to achieve a complete response (CR), meaning no signs of cancer, measured at one year. The study is currently evaluating two separate groups of patients: one with FL and one with MZL.

Study design
This is a Phase 2 study designed to evaluate the safety and effectiveness of the drug combination. It plans to enroll 65 participants across two independent groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure complete response at 1 year, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06792825

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~65 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:TafasitamabRituximabLenalidomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response (CR)
Measured over 1 year

Conditions

Follicular Lymphoma
Marginal Zone Lymphoma

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NCT06792825

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Masonic Cancer Center

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Sanjal Desai, MD
[email protected]
612-624-9452
Email the study team

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Eligibility criteria

Inclusion

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)
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

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.

What this trial measures

  • Complete response (CR)1 year

    Estimate complete response (CR) at the end of study (after 12 cycles around 1 year) regimen of tafasitamab with lenalidomide and rituximab.