A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
NCT05800366 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2026-03-05
Summary
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
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
Interventions
- DRUG
-
Per standard care, orally
- DRUG
-
Glofitamab
human IgG1-bispecific antibody, via IV infusion
- DRUG
-
Polatuzumab
an antibody drug conjugate (ADC) that contains a humanized IgG1 anti-human CD79b monoclonal antibody, via IV infusion
- DRUG
-
Per standard care, via IV infusion
- DRUG
-
Doxorubicin Hydrochloride
Per standard care, via IV infusion
- DRUG
-
Per standard care, via IV infusion
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Jennifer Crombie, MD
lead OTHER
Principal Investigators
-
Jennifer Crombie, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-06
- Primary Completion
- 2026-09-15
- Completion
- 2029-09-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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