RecruitingPhase 2NCT05800366

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

Sponsor

Jennifer Crombie, MD

Enrollment

41 participants

Start Date

Apr 6, 2023

Study Type

INTERVENTIONAL

Conditions

Lymphoma Lymphoma, Large B-Cell, Diffuse

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination of cancer drugs — glofitamab and polatuzumab — added to standard chemotherapy (R-CHP) for people newly diagnosed with a fast-growing type of lymphoma called diffuse large B-cell lymphoma (DLBCL). It is specifically for people whose cancer is considered high-risk. **You may be eligible if:** - You are 18 or older - You have been newly diagnosed with CD20-positive DLBCL or a related high-grade B-cell lymphoma - You have not yet received any treatment for this lymphoma - Your cancer is considered intermediate to high risk (IPI score of 2–5) - Your heart, blood counts, liver, and kidneys are functioning adequately **You may NOT be eligible if:** - You have already started treatment for this lymphoma - Your heart function is below acceptable levels - Your blood counts are too low (not due to the lymphoma itself) - You have certain other active cancers - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGlofitamab

human IgG1-bispecific antibody, via IV infusion

DRUGPolatuzumab

an antibody drug conjugate (ADC) that contains a humanized IgG1 anti-human CD79b monoclonal antibody, via IV infusion

DRUGRituximab

Per standard care, via IV infusion

DRUGDoxorubicin Hydrochloride

Per standard care, via IV infusion

DRUGCyclophosphamide

Per standard care, via IV infusion

DRUGPrednisone

Per standard care, orally

Locations(3)

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05800366

Related Trials

Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

NCT052379863 locations

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

NCT047398131 location

Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas

NCT032585671 location

A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)

NCT073023473 locations

Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors

NCT064413315 locations