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Tafasitamab and Rituximab for Newly Diagnosed Follicular Lymphoma

This study is testing how well two medicines, tafasitamab and rituximab, work together to treat newly diagnosed follicular lymphoma. Follicular lymphoma is a type of cancer that affects white blood cells. Both tafasitamab and rituximab are monoclonal antibodies, which are proteins that can help your immune system fight cancer cells. The study aims to see how many patients achieve complete remission (meaning the cancer is no longer detectable) within one year of starting treatment. You may be able to join if you are 18 or older, have a confirmed diagnosis of follicular lymphoma (grades 1, 2, 3A, or classic), and meet specific criteria for needing treatment, such as having large tumors or many affected lymph nodes. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 30 participants.
What's involved
You would receive rituximab and tafasitamab intravenously (through a vein) over several cycles. You would also undergo blood sample collection, bone marrow aspiration, bone marrow biopsy, PET scans, and CT scans throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After completing treatment, patients will be followed periodically for up to 5 years.

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

NCT07731789

Tafasitamab and Rituximab for the Treatment of Newly Diagnosed Follicular Lymphoma

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~30 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:RituximabTafasitamabBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed Tomography

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete remission at the best response
Measured over Up to 1 year of starting treatment

Conditions

Classic Follicular Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma

Explore related trials

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NCT07731789

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.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

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

Study leadership

  • Mengyang Di, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Mengyang Di, MD, PhD
[email protected]
206-606-2519
Email the study team

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Eligibility criteria

Inclusion

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 ≥ 8 g/dL (unless due to bone marrow involvement by lymphoma)
Total bilirubin ≤ 2.0 mg/dL, except for patients with documented lymphoma involvement of liver or with a known history of Gilbert's disease
Alkaline phosphatase/aspartate aminotransferase (AST)/(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 × institutional upper limit of normal, except for patients with documented liver involvement
Creatinine clearance ≥ 30 ml/min
Fertile male and women of child bearing potential (WOCBP) patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the last dose of study treatment
Ability to understand and willingness to sign a written informed consent document

Exclusion

FL grade 3B or transformed FL
Patients receiving any other investigational agents
Patients with known central nervous system involvement of lymphoma
History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the primary investigator (PI) may be included
Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
Uncontrolled intercurrent illness such as: history of myocardial infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (\> 10 mg daily prednisone equivalent)
Prior use of any monoclonal antibody within 4 weeks before the first administration
Breastfeeding or pregnant women
Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody are eligible if the corresponding polymerase chain reaction (PCR) test is negative prior to enrollment. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis as per institutional guidelines
History of human immunodeficiency virus (HIV) infection uncles the viral load is undetectable and CD4 count is at least 400
History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Major surgery (excluding lymph node biopsy) within 28 days prior to signing the informed consent form (ICF) unless the participant is recovered at the time of signing the ICF
Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of cycle 1
Administration of a live vaccine within 28 days prior to the start of study treatment (cycle 1 day 1)
History of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory drugs, rituximab, other monocolonal antibodies (mAbs), and/or the excipients contained in the study drug formulations

What this trial measures

  • Complete remission at the best responseUp to 1 year of starting treatment

    Assessed by positron emission tomography (PET)/computed tomography (CT) and diagnostic CT scans based on Lugano criteria. Will report the number of complete response (CR) at the best response within one year of starting study treatment and the estimated CR rate with 95% exact binomial confidence interval (CI).