Can a Triple-Drug combo wipe out Slow-Growing lymphomas?
NCT ID NCT06792825
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding tafasitamab to the standard combination of lenalidomide and rituximab can improve complete responses in people with untreated follicular lymphoma or marginal zone lymphoma. Participants receive the three-drug regimen for about a year, and researchers will measure how many achieve a complete response at the end of treatment. The study enrolls adults who need treatment but have not yet received any systemic therapy for their lymphoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tafasitamab combined with lenalidomide and rituximab
- What this could lead to
- If successful, this combination could become a new first-line treatment option for people with these slow-growing lymphomas, potentially improving complete response rates.
- What could go wrong
- This is an early-phase trial with a modest number of participants, so results may not hold up in larger studies. Side effects from the drug combination are possible, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Jul 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Follicular lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Masonic Cancer Center
RECRUITINGMinneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- Which lymphoma drug combo works best? a new study aims to find out
- Can engineered immune cells beat tough B-Cell cancers?
- Can a new drug delay the need for lymphoma treatment?