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Monoclonal Antibodies

Glofitamab + Polatuzumab-R-CHP for Diffuse Large B-Cell Lymphoma

Phase 2

Recruiting

Led By Philippe Armand, MD

Research Sponsored by Philippe Armand, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying a combination of drugs to treat high-risk diffuse large B-cell lymphoma.

Who is the study for?

This trial is for adults over 18 with untreated high-risk diffuse large B-cell lymphoma (DLBCL), a type of cancer. They must have an IPI score of 2-5, be in decent physical shape (ECOG 0-1-2), and their heart and other organs must work well. Women who can have babies and men must agree to use birth control. People with prior organ transplants, recent cancer treatments, or certain infections like HIV can't join.Check my eligibility

What is being tested?

The study tests Glofitamab combined with Polatuzumab alongside standard chemo R-CHP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone) for treating DLBCL. Glofitamab is a T-cell bispecific antibody; Polatuzumab is an antibody-drug conjugate; R-CHP are established chemotherapy drugs.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, low blood cell counts leading to increased infection risk or bleeding problems, heart issues due to doxorubicin hydrochloride, nausea from chemotherapy drugs like cyclophosphamide and prednisone-related weight gain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Response (CR) Rate

Secondary outcome measures

1-Year Progression Free Survival rate

Change in ctDNA level from Baseline to 2 cycles by Objective Response Status or PFS or OS

Dose-Limiting Toxicity (DLT)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Polatuzumab + Glofitamab + R-CHExperimental Treatment6 Interventions

-Participants will receive treatment interventions as outlined: Experimental: Safety Lead-In Phase of 6 Participants, Total Enrollment of 40 Participants Polatuzumab, once, predetermined day and dosage per cycle, per protocol Cycles 1 - 6 R-CHP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride once, predetermined day and dosage per cycle, per protocol Cycles 1 - 6: Prednisone) 5 days, predetermined day and dosage per cycle, per protocol Cycles 1 - 6: Glofitamab twice, predetermined day and dosage per cycle, per protocol Cycle 3-6 once, predetermined day and dosage per cycle, per protocol Cycle 7-8 Participants who need urgent therapy are also allowed to proceed with one cycle of R-CHOP for 1 cycle per standard of care. Participants will be followed for up to 5 years post-treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Glofitamab

2021

Completed Phase 1

~60

Rituximab

1999

Completed Phase 4

~1880

Prednisone

2014

Completed Phase 4

~2370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Philippe Armand, MD, PhDLead Sponsor

Jennifer Crombie, MDLead Sponsor

1 Previous Clinical Trials

35 Total Patients Enrolled

1 Trials studying Lymphoma

35 Patients Enrolled for Lymphoma

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,103 Total Patients Enrolled

100 Trials studying Lymphoma

10,620 Patients Enrolled for Lymphoma

Media Library

Lymphoma Research Study Groups: Polatuzumab + Glofitamab + R-CH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still slots available for participants of this research?

"The information on clinicaltrials.gov states that this particular study is no longer recruiting participants, with the last updates being made April 4th 2023. Although recruitment for this trial has concluded, 1756 other medical trials are actively seeking candidates at present."

Answered by AI

What are the potential health risks associated with administering Polatuzumab, Glofitamab and R-CH to patients?

"Based on available data, our team rates the safety of Polatuzumab + Glofitamab + R-CH as a 2. This reflects that Phase 2 trials have yielded some insight into its security but there is no evidence yet to support efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jennifer Crombie, MD 2023. "A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05800366.

All > Diffuse Large B Cell Lymphoma