Actively Recruiting
Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma
Led by University of Washington · Updated on 2026-03-03
56
Participants Needed
1
Research Sites
578 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 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). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.
CONDITIONS
Official Title
Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated aggressive B-cell large B-cell lymphoma with features predicting poor response to standard R-CHOP therapy
- Planned to receive full 6 cycles of chemoimmunotherapy with DA-EPOCH-R
- Diagnosis includes high-grade B-cell lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, EBV-positive DLBCL, ALK-positive large B-cell lymphoma, or unclassifiable B-cell lymphoma
- Able and willing to provide written informed consent
- Age 18 years or older at consent
- Measurable disease with at least one nodal site ≥1.5 cm or extranodal site ≥1.0 cm on CT or FDG-PET
- ECOG performance status 0 to 2
- Left ventricular ejection fraction ≥50% by MUGA scan or echocardiography
- Absolute neutrophil count ≥1,000/uL unless due to marrow lymphoma infiltration
- Platelet count ≥75,000/mcL unless due to marrow lymphoma infiltration or hypersplenism
- Hemoglobin ≥8 g/dL unless due to marrow lymphoma infiltration without recent transfusion
- Creatinine clearance or GFR ≥40 mL/min
- Serum total bilirubin ≤1.5 times upper limit of normal (ULN); ≤3.0 times ULN if Gilbert disease
- Direct bilirubin ≤ULN if total bilirubin >1.5 ULN
- AST and ALT ≤2.5 times ULN or ≤5 times ULN if liver involved
- INR or PT ≤1.5 times ULN unless on anticoagulants within therapeutic range
- aPTT ≤1.5 times ULN unless on anticoagulants within therapeutic range or antiphospholipid antibody positive
- Women of childbearing potential must use effective contraception or abstain during treatment and specified follow-up periods and have negative pregnancy test
- Men must use condoms or abstain during treatment and specified follow-up periods and agree to refrain from sperm donation
- For Arm B only: Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
You will not qualify if you...
- Allergy or contraindication to any study drugs including glofitamab, tocilizumab, EPCH-R, or anthracyclines
- Prior systemic lymphoma treatment except corticosteroids; prior radiotherapy allowed if not used for measurable disease
- Diagnosis of Richter's transformation from CLL/SLL
- Diagnosis of Burkitt lymphoma
- Prior organ transplantation
- Current grade greater than 1 peripheral neuropathy or demyelinating Charcot-Marie-Tooth disease
- Prior systemic treatment for indolent lymphoma
- Use of monoclonal antibodies within 3 months before treatment start
- Use of investigational therapy within 28 days before treatment start
- Live vaccine within 28 days before treatment start or during study
- Excessive corticosteroid use beyond allowed limits before treatment
- History of other malignancy affecting study compliance or results unless specifically allowed
- Significant uncontrolled diseases including advanced heart or lung disease
- Recent major surgery within 4 weeks prior to treatment
- Clinically significant abnormal ECG
- Active infection requiring systemic treatment
- Positive chronic hepatitis B surface antigen test unless managed with antiviral therapy
- Positive hepatitis C antibody unless PCR negative
- Uncontrolled HIV infection
- History of progressive multifocal leukoencephalopathy
- Pregnancy, lactation, or planning pregnancy
- For Arm B only: history of hemophagocytic lymphohistiocytosis, chronic active Epstein-Barr virus infection, Waldenström macroglobulinemia, CNS disease, active autoimmune disease not well controlled, significant liver disease, suspected tuberculosis, or recent grade 3 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
R
Ryan Lynch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here