Actively Recruiting
A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
Led by M.D. Anderson Cancer Center · Updated on 2026-03-16
36
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if giving mosunetuzumab in combination with polatuzumab vedotin, tafasitamab, and lenalidomide can help to control relapsed/refractory FL and DLBCL.
CONDITIONS
Official Title
A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed CD20-positive follicular lymphoma grade 1-3a or relapsed CD20-positive diffuse large B-cell lymphoma
- Evidence of disease progression or lack of response after at least one prior treatment
- Age 18 years or older
- At least one measurable disease site greater than 1.5 cm
- Adequate blood counts: hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1.0 x 10^9/L; platelets ≥ 75 x 10^9/L
- Liver function: bilirubin < 1.5 times upper limit of normal (ULN), with exceptions for Gilbert's syndrome; AST and ALT ≤ 3 times ULN or ≤ 5 times ULN if liver metastases present
- Kidney function: creatinine clearance ≥ 30 ml/min
- Willingness to receive blood transfusions if needed
- Men not surgically sterile must agree to use barrier contraception and ensure female partners use contraception during and after treatment as specified
- Women of reproductive potential must use two effective contraception methods for at least 12 months after last treatment dose
- Negative pregnancy test before starting lenalidomide and agreement to ongoing pregnancy testing
- Enrollment in Revlimid REMS® program and compliance with its requirements
- Ability to take daily aspirin or equivalent anticoagulation
You will not qualify if you...
- Known allergy to any study drug
- Previous treatment with polatuzumab vedotin, mosunetuzumab, CD20-directed bispecific antibodies, tafasitamab, or lenalidomide
- Autologous stem cell transplant within 100 days before study treatment
- CAR-T therapy within 30 days before treatment
- Eligibility for autologous stem cell transplant with relapsed/refractory diffuse large B-cell lymphoma
- Prior allogeneic stem cell transplant or solid organ transplant
- History of severe allergic reactions to monoclonal antibody therapy
- Use of corticosteroids or immunosuppressive drugs within 2 weeks before treatment, except certain allowed uses
- Recent chemotherapy or immunotherapy within 4 weeks before treatment
- Recent radiotherapy within 2 weeks before treatment unless meeting specific criteria
- History of other cancers within 2 years, except certain skin or cervical cancers
- Serious medical conditions that increase risk or affect study compliance
- History of hemophagocytic lymphohistiocytosis or autoimmune diseases excluding some stable conditions
- Active infections including HIV, hepatitis B or C, tuberculosis, or chronic active Epstein-Barr virus
- Vaccination with live vaccines within 28 days before treatment
- Peripheral neuropathy grade 2 or higher
- Pregnant or breastfeeding women
- Known central nervous system involvement with lymphoma
- Contraindications to required drugs or supportive treatments
- Recent major surgery or unhealed wounds
- History of stroke or intracranial hemorrhage within 6 months
- Active bleeding or bleeding disorders
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Abnormal clotting test results
- Concurrent participation in another therapeutic clinical trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason Westin, MD, MS, FACP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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