Actively Recruiting
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
Led by Jennifer Crombie, MD · Updated on 2026-03-05
41
Participants Needed
3
Research Sites
336 weeks
Total Duration
On this page
Sponsors
J
Jennifer Crombie, MD
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this research study is to evaluate the combination of study drugs, Glofitamab and Polatuzumab, and a standard chemotherapy regimen, R-CHP, as a treatment for high-risk diffuse large B-cell lymphoma. The names of the treatment interventions involved in this study are: * Glofitamab (T-cell bispecific antibody) * Polatuzumab (antibody-drug conjugate) * R-CHP (a chemotherapy regimen comprised of Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, and Prednisone)
CONDITIONS
Official Title
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL), including specific subtypes as per 2016 WHO classification
- Availability of tumor tissue from archival samples within 90 days or fresh biopsy before enrollment
- International Prognostic Index (IPI) score between 2 and 5
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Age 18 years or older at the time of signing informed consent
- Left ventricular ejection fraction (LVEF) of 50% or higher on cardiac MUGA scan or echocardiogram
- Adequate blood counts: hemoglobin ≥ 9.0 g/dL without recent transfusion, absolute neutrophil count (ANC) ≥ 1,000/µL, platelet count ≥ 75,000/µL
- Adequate organ function including bilirubin ≤ 1.5 times upper limit of normal (ULN) or ≤ 3 times ULN in Gilbert's disease, prothrombin time (PT) or INR ≤ 1.5 times ULN without therapeutic anticoagulation, liver enzymes (AST/ALT) ≤ 2.5 times ULN, and creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 40 ml/min
- At least one measurable lymphoma lesion > 1.5 cm on CT scan and FDG-avid on PET/CT
- Women of childbearing potential must use effective contraception during and after treatment as specified
- Men must agree to abstain or use condoms during and after treatment and not donate sperm during this period
- Participants with chronic hepatitis B or C must have undetectable viral loads and agree to monitoring and treatment as needed
- Ability to understand and sign informed consent
You will not qualify if you...
- Allergy or severe reaction to study drugs, anthracyclines, or corticosteroids
- Prior organ transplantation
- History or current diagnosis of indolent lymphoma or specific lymphoma subtypes such as follicular lymphoma grade 3B, grey-zone lymphoma, primary mediastinal large B-cell lymphoma, Burkitt lymphoma, CNS lymphoma, primary effusion DLBCL, or primary cutaneous DLBCL
- Prior treatment for DLBCL except short-term corticosteroids or one cycle of R-CHOP
- Prior radiotherapy to the mediastinal or pericardial region
- Prior cytotoxic drug treatment within 5 years or anti-CD20 antibody use
- Use of monoclonal antibodies within 3 months or investigational therapy within 28 days before treatment
- High-dose corticosteroid use (>30 mg/day prednisone or equivalent) not for lymphoma symptom control
- History of other malignancies except certain treated cancers with no active disease for 2 or more years
- Pregnant or lactating women
- Active or recent serious infections requiring hospitalization or IV antibiotics
- HIV or HTLV-1 positive status
- Significant liver disease or alcohol abuse
- Severe or uncontrolled cardiovascular or pulmonary disease
- History of recent stroke, intracranial hemorrhage, or seizure disorder
- Grade 2 or higher peripheral neuropathy or demyelinating Charcot-Marie-Tooth disease
- Major surgery within 4 weeks before treatment
- Active autoimmune disease requiring therapy except stable thyroid disease or type 1 diabetes
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Clare Phinney
CONTACT
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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