Actively Recruiting
A Pilot Study of Polatuzumab Vedotin With or Without Glofitamab Combined With Dose-Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin for Initial Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas
Led by University of Washington · Updated on 2026-03-03
56
Participants Needed
1
Research Sites
260 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
Researchers are evaluating the side effects and safety of polatuzumab vedotin combined with chemotherapy, with or without glofitamab, for patients with untreated aggressive large B-cell lymphoma. This phase I trial focuses on lymphomas that grow and spread quickly and cause severe symptoms, aiming to understand how these treatments work together and their tolerability. Polatuzumab vedotin targets cancer cells by delivering a toxic agent directly to them, while glofitamab may block cancer cell growth. Other drugs in the chemotherapy mix work by stopping cancer cell growth and spread in different ways. Participants are assigned to one of two treatment groups. One group receives rituximab, polatuzumab vedotin, prednisone, etoposide, doxorubicin, cyclophosphamide, and filgrastim in repeated cycles every 21 days for up to six cycles. The other group receives the same treatment plus glofitamab starting from the second cycle. Treatments involve intravenous infusions and oral medication. Throughout the study, patients undergo scans including MUGA or echocardiography, FDG PET, CT scans, bone marrow biopsy and aspiration, and blood sample collection. After treatment, patients are followed for up to five years to monitor health. During the trial, participants will have regular imaging and laboratory tests to assess their response and monitor safety. Researchers focus on tracking side effects up to 30 days after treatment and how many patients can complete the full six cycles without stopping due to reasons other than disease progression. Participants heart function, blood counts, and organ health are also carefully checked. The trial involves careful monitoring to understand how well patients tolerate the treatments and to gather data for future care options.
CONDITIONS
Brief 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 planned for full 6-cycle chemoimmunotherapy
- Diagnosis includes specific lymphoma types such as high-grade B-cell lymphoma with MYC and BCL2/BCL6 translocations, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and others per 2016 WHO classification
- Age 18 years or older at consent
- Measurable disease with nodal or extranodal sites meeting size criteria on CT or FDG-PET
- Eastern Cooperative Oncology Group performance status 0-2
- Left ventricular ejection fraction at least 50% by MUGA scan or echocardiogram
- Absolute neutrophil count at least 1,000/uL unless marrow involvement
- Platelets at least 75,000/mcL unless marrow involvement or hypersplenism
- Hemoglobin at least 8 g/dL unless marrow involvement without recent transfusion
- Creatinine clearance or GFR at least 40 mL/min
- Total bilirubin less than or equal to 1.5 times upper limit of normal, with exceptions for Gilbert disease
- Liver enzymes AST and ALT within specified limits
- Coagulation tests INR, PT, aPTT within limits or on therapeutic anticoagulants
- Women of childbearing potential must use effective contraception and have negative pregnancy test
- Men must use contraception or abstain and agree not to donate sperm during and after treatment
- For Arm B, negative COVID-19 test within 7 days prior to enrollment
You will not qualify if you...
- Allergy or contraindication to study drugs including polatuzumab vedotin, glofitamab, tocilizumab, or components of chemoimmunotherapy
- Prior systemic lymphoma treatment except corticosteroids; prior radiotherapy allowed if not target disease site
- Richter's transformation from chronic lymphocytic leukemia not allowed
- Diagnosis of Burkitt lymphoma
- Prior organ transplantation
- Grade greater than 1 peripheral neuropathy or specific neuropathies
- Prior monoclonal antibody use within 3 months before cycle 1
- Prior investigational therapy within 28 days before cycle 1
- Live vaccination within 28 days before cycle 1 or during treatment
- Recent major surgery within 4 weeks before cycle 1
- Significant uncontrolled cardiovascular or pulmonary disease
- Clinically significant abnormal ECG
- Active infections requiring systemic treatment at start of treatment
- Positive chronic hepatitis B surface antigen or active hepatitis C infection
- Uncontrolled HIV infection
- History of progressive multifocal leukoencephalopathy
- Pregnancy or lactation
- For Arm B, additional exclusions including known hemophagocytic lymphohistiocytosis, chronic active Epstein-Barr virus infection, certain CNS diseases, uncontrolled autoimmune diseases, significant liver disease, active tuberculosis, or recent severe infections
Research Team
R
Ryan Lynch
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