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Can a Triple-Drug combo wipe out Slow-Growing lymphomas?

NCT ID NCT06792825

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

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