Not Yet RecruitingPhase 2

Tafasitamab and Rituximab for the Treatment of Newly Diagnosed Follicular Lymphoma

United States30 participantsStarted 2026-10-31

Plain-language summary

This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving tadasitamab and rituximab may work well to treat patients with newly diagnosed follicular lymphoma.

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: * Age ≥ 18 years old * Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma) * Meeting any one of the following criteria for therapy initiation: * Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm. * Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm. * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months) attributed to FL. * Risk of local compressive symptoms that may result in organ compromise. * Splenomegaly with the inferior margin below the umbilical line or splenic lesion without splenomegaly. * Significant cytopenia (absolute neutrophil count \< 1500/mm3, platelets \< 100,000/uL, hemoglobin \< 10 g/dL) * Leukemia (\> 5,0000/uL circulating lymphocytes) * Pleural effusion or ascites attributed to lymphoma * Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Absolute neutrophil count ≥ 1500/mm\^3 (unless due to lymphoma involvement of the bone marrow or spleen) * Platelets ≥ 75,000/mm\^3 (unless due to bone marrow involvement by lymphoma) * Hemoglobin ≥…

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

Complete remission at the best response

Timeframe: Up to 1 year of starting treatment

Trial details

NCT IDNCT07731789

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-10-31

Contact for this trial

Mengyang Di, MD, PhD

206-606-2519 mydi@fredhutch.org

View on ClinicalTrials.gov More Classic Follicular Lymphoma trials