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

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byJennifer Crombie, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Philippe Armand, MD, PhD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a combination of drugs to treat high-risk diffuse large B-cell lymphoma in patients who have not been treated before. The drugs help the immune system attack cancer and directly kill cancer cells. The standard treatment for diffuse large B-cell lymphoma (DLBCL) includes rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

Research Team

Jennifer Crombie, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I have a lymphoma lesion that shows up on scans.

I have chronic hepatitis B with no detectable virus in my blood.

Women of childbearing potential must use effective contraception

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Exclusion Criteria

I have tested positive for HIV or HTLV-1.

I am not allergic to the drugs used in this study.

I have not had an active infection or a flare-up of a hidden infection in the last 2 weeks.

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Treatment Details

Interventions

Glofitamab (Monoclonal Antibodies)
Polatuzumab (Monoclonal Antibodies)
R-CHP (Chemotherapy)

Trial OverviewThe 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.

Participant Groups

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.