NCT05800366

A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Jennifer Crombie, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This study is an open-label, multi-center, single-arm phase II study of glofitamab plus polatuzumab and R-CHP for patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL). * Study procedures include screening for eligibility, study evaluations, radiological scans of tumors, tumor biopsies, TTE/MUGA scans, and blood collections. * All participants will receive two cycles of polatuzumab -R-CHP and four cycles of glofitamab- polatuzumab -R-CHP. After completion of chemotherapy patients will receive two additional cycles of glofitamab alone. * Participants receive study treatment for up to 8 cycles of treatment and will be followed for 5 years. * It is expected that about 40 people will take part in this research study. * This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. * The U.S. Food and Drug Administration (FDA) has not approved glofitamab as a treatment for any disease. * The FDA has approved polatuzumab in combination with rituximab and another chemotherapy agent, bendamustine, for DLBCL that has already been treated with two prior treatments, but not as an initial therapy. * The R-CHP regimen is FDA approved and standard care for cancer treatment. * Genentech is supporting this research study by providing drug and funding for this trial.

Conditions

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
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	Rituximab	Per standard care, via IV infusion
DRUG	Doxorubicin Hydrochloride	Per standard care, via IV infusion
DRUG	Cyclophosphamide	Per standard care, via IV infusion
DRUG	Prednisone	Per standard care, orally

Timeline

• Start date: 2023-04-06
• Primary completion: 2026-09-15
• Completion: 2029-09-15
• First posted: 2023-04-05
• Last updated: 2026-03-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study