Actively Recruiting
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
30
Participants Needed
8
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.
CONDITIONS
Official Title
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed DLBCL NOS, high-grade B-cell lymphoma, or transformed indolent lymphoma per WHO 2022 criteria
- Relapsed or refractory DLBCL after one or more prior therapies, including patients with a Deauville score 63 within 90 days after CAR T-cell therapy
- Patients who progressed or relapsed after prior polatuzumab vedotin are eligible
- Measurable disease by CT or PET with one or more sites 61.5 cm in longest dimension
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 63 60%)
- Life expectancy of at least 12 weeks
- Absolute neutrophil count 61,000/mcL
- Platelet count 65,000/mcL without transfusion for 2 weeks before first treatment
- Hemoglobin 69 g/dL
- Total bilirubin 61.5 times institutional upper limit of normal (ULN), or 63 times ULN if Gilbert disease
- AST and ALT 63 times ULN (up to 5 times ULN for liver involvement)
- Alkaline phosphatase 62.5 times ULN (up to 5 times ULN for liver or bone involvement)
- Creatinine clearance 630 mL/min/1.73 m2
- INR and aPTT 61.5 times ULN (if not on therapeutic anticoagulation; stable dose required if anticoagulated)
- HIV patients on effective therapy with undetectable viral load within 6 months
- Patients with controlled chronic hepatitis B or cured hepatitis C
- Patients with treated brain metastases and no progression on follow-up imaging
- Patients with prior or concurrent malignancies not interfering with study
- Women of childbearing potential must use contraception or remain abstinent during treatment and specified follow-up periods
- Men must use condoms or remain abstinent during treatment and specified follow-up periods
- Ability to understand and sign informed consent
- Agreement to comply with lenalidomide risk minimization plan
You will not qualify if you...
- Plasmablastic lymphoma, primary mediastinal B-cell lymphoma, or gray zone lymphoma
- Unresolved adverse events from prior cancer therapy above grade 1 except alopecia
- Receiving any other investigational treatments
- Conditions or lab abnormalities posing unacceptable risk or confounding data
- Allergic reactions to mosunetuzumab or related agents
- Uncontrolled active infections or recent severe infections requiring IV antibiotics or hospitalization
- Active central nervous system lymphoma involvement
- Pregnancy, breastfeeding, or planning pregnancy during study and specified post-treatment periods
- History or symptoms of significant cardiac disease beyond NYHA class 2
- Known or suspected chronic active Epstein-Barr virus infection
- Significant other medical conditions including grade >1 peripheral neuropathy, prior organ transplant, history of HLH, PML, or active autoimmune disease
- Patients with stable autoimmune hypothyroidism or controlled type 1 diabetes may be eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Suspended
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
6
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
8
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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