What side effects are associated with this type of intervention?

Common side effects of treatments for lymphoma, such as those being studied in the trial (Glofitamab, Polatuzumab, and R-CHP), include infusion-related reactions, which can range from mild to severe and may include fever, chills, and hypotension. T-cell bispecific antibodies like Glofitamab can cause cytokine release syndrome, leading to symptoms such as fever, nausea, headache, and hypotension. Antibody-drug conjugates like Polatuzumab may result in peripheral neuropathy, fatigue, and gastrointestinal issues. The R-CHP chemotherapy regimen, which includes Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone, is associated with myelosuppression, increased risk of infections, nausea, vomiting, hair loss, and cardiotoxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for lymphoma that are similar to those being studied in the trial. Polatuzumab vedotin, an antibody-drug conjugate targeting CD79B, has been approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab. Rituximab, a monoclonal antibody targeting CD20, is a key component of the R-CHOP regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone), which is a standard treatment for DLBCL. While Glofitamab, a T-cell bispecific antibody, is still under investigation, other bispecific antibodies like blinatumomab have been approved for certain types of leukemia, indicating a growing interest in this class of drugs for hematologic malignancies.

What other types of research exist?

Promising novel alternatives for lymphoma treatment in 2024 include: 1) Bispecific antibodies like Epcoritamab, which targets CD3 and CD20. 2) Antibody-drug conjugates such as Loncastuximab Tesirine, targeting CD19. 3) CAR T-cell therapies like Lisocabtagene Maraleucel (Liso-cel) and Axicabtagene Ciloleucel (Axi-cel). 4) Novel small molecule inhibitors like Bruton’s tyrosine kinase (BTK) inhibitors, including Zanubrutinib and Pirtobrutinib. These alternatives offer different mechanisms of action and may provide additional options for patients with lymphoma.

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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

No Placebo-Only Group

Summary

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).

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response (CR) Rate

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Glofitamab

2021

Completed Phase 1

~60

Rituximab

1999

Completed Phase 4

~2990

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Cyclophosphamide

2010

Completed Phase 4

~2310

Prednisone

2014

Completed Phase 4

~2500

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lymphoma treatments such as Glofitamab, Polatuzumab, and the R-CHP regimen work through distinct mechanisms to target cancer cells. Glofitamab is a T-cell bispecific antibody that binds to both T-cells and lymphoma cells, facilitating the immune system's attack on the cancer. Polatuzumab is an antibody-drug conjugate that delivers cytotoxic agents directly to lymphoma cells, minimizing damage to healthy cells. The R-CHP regimen combines Rituximab, a monoclonal antibody targeting CD20 on B-cells, with chemotherapy agents Cyclophosphamide, Doxorubicin, and Prednisone, which kill rapidly dividing cells. These mechanisms are crucial for lymphoma patients as they offer targeted and effective ways to eliminate cancer cells while aiming to reduce side effects and improve overall outcomes.