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
156 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
Researchers are evaluating the combination of study drugs Glofitamab and Polatuzumab with a standard chemotherapy regimen called R-CHP as a treatment for patients with high-risk diffuse large B-cell lymphoma (DLBCL). This phase II clinical trial focuses on patients who have not received prior treatment for this type of lymphoma. The study aims to assess how well these drugs work together and to understand their safety profile in this patient population. Participants in this open-label, single-arm study will receive treatment over up to 8 cycles. Initially, they will get two cycles of Polatuzumab combined with R-CHP chemotherapy, followed by four cycles of Glofitamab with Polatuzumab and R-CHP. After completing chemotherapy, participants will receive two additional cycles of Glofitamab alone. The drugs are administered mainly through intravenous infusions, with Prednisone taken orally. Participants who need urgent therapy may receive one cycle of R-CHOP chemotherapy. Following treatment, patients will be monitored for up to 5 years. During the study, participants will undergo screening evaluations, tumor scans, tumor biopsies, heart function tests, and blood draws. Researchers will monitor treatment effects by measuring the rate of complete response 28 days after the final treatment cycle, as well as other outcomes such as treatment toxicities, overall response, and progression-free survival over time. The study will also track changes in tumor DNA levels. Participants' health will be followed for several years to collect long-term data on treatment outcomes and safety.
CONDITIONS
Brief 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 or related subtypes as defined by the 2016 WHO classification
- Availability of tumor tissue from recent 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 informed consent
- Left ventricular ejection fraction of 50% or higher confirmed by heart scan
- Adequate blood counts and organ function as defined in the criteria
- At least one measurable lymphoma lesion larger than 1.5 cm on PET/CT scan
- Women of childbearing potential must agree to use effective contraception during treatment and specified follow-up periods
- Men must agree to use condoms or abstain from sexual activity with partners of childbearing potential and avoid sperm donation during treatment and follow-up
- Undetectable hepatitis B or C viral load if previously infected
- Ability to understand and sign informed consent
You will not qualify if you...
- History of allergies or severe reactions to study drug components or related antibodies
- Prior organ transplantation
- Prior diagnosis of certain lymphoma subtypes such as follicular lymphoma grade 3B, Burkitt lymphoma, or CNS lymphoma
- Previous treatment for diffuse large B-cell lymphoma except short corticosteroid use or one cycle of R-CHOP
- Prior radiotherapy to the chest area
- Chemotherapy or monoclonal antibody treatments within defined recent timeframes
- Use of high-dose corticosteroids for reasons other than lymphoma symptom control
- History of other cancers unless treated and disease-free for at least 2 years with exceptions approved by investigators
- Pregnant or breastfeeding women
- Active or recent serious infections
- Known HIV or HTLV-1 infection
- Significant liver disease or alcohol abuse
- Serious heart or lung diseases that could interfere with the study
- Recent stroke, seizure disorders, or neurological diseases
- Peripheral neuropathy of moderate or higher severity
- Major surgery within 4 weeks before starting treatment
- Active autoimmune diseases needing therapy except stable thyroid disease or type 1 diabetes
- Known or suspected hemophagocytic lymphohistiocytosis (HLH)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (8 cycles of 21 days each)
Participants receive up to 8 cycles of treatment involving combinations of polatuzumab, glofitamab, rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone administered by IV infusion or orally as per protocol.
Up to 8 visits for treatment cycles
Duration - Up to 5 years
Participants are followed for safety and effectiveness assessments for up to 5 years after completing treatment.
Regular follow-up visits over 5 years
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
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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