What side effects are associated with this type of intervention?

Common treatments for Hodgkin's Lymphoma, particularly those involving monoclonal antibodies like Mosunetuzumab and Rituximab, often target the CD20 protein on B cells. These treatments can lead to side effects such as infusion-related reactions, including fever, chills, and nausea. Other potential side effects include increased risk of infections due to immunosuppression, fatigue, and cytopenias (reduced blood cell counts). Additionally, patients may experience mild alopecia (hair thinning) and skin reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Rituximab, a monoclonal antibody targeting CD20, has been approved by the FDA for the treatment of various lymphomas, including Hodgkin's Lymphoma. It works by binding to the CD20 protein on B cells, aiding the immune system in killing cancer cells. Other similar treatments include Brentuximab Vedotin, which targets CD30, another protein found on Hodgkin's Lymphoma cells. These treatments have paved the way for newer therapies like Mosunetuzumab, which also targets CD20 and is being studied for its potential to improve survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma.

What other types of research exist?

Promising novel alternatives to Mosunetuzumab for Hodgkin's Lymphoma patients include Pembrolizumab and Dostarlimab, both of which are immune checkpoint inhibitors. Pembrolizumab targets PD-1, while Dostarlimab targets PD-L1, aiding the immune system in killing cancer cells. These agents have shown efficacy in various cancers, including Hodgkin's Lymphoma, and are approved for use in cases with specific genetic markers such as dMMR or MSI-H.

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Monoclonal Antibodies

Immunotherapy for Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Dai Chihara

Research Sponsored by National Cancer Institute (NCI)

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 assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called mosunetuzumab against the usual treatment, rituximab, for patients with a type of cancer called NLPHL. Both treatments help the immune system find and kill cancer cells by targeting a specific protein on these cells. The goal is to see if mosunetuzumab can improve survival better than rituximab.

Who is the study for?

This trial is for adults with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL), either untreated or previously treated but not within the last 6 months if rituximab was used. Participants need to have symptoms like fever, weight loss, night sweats, or measurable disease and can't just be observed. They must also have good organ function and performance status.

What is being tested?

The study compares mosunetuzumab with the usual treatment of rituximab in improving survival for NLPHL patients. Both drugs are monoclonal antibodies targeting CD20 on B cells and cancer cells, potentially helping the immune system destroy these cells.

What are the potential side effects?

As both treatments involve monoclonal antibodies that target immune responses, potential side effects may include infusion reactions, fatigue, allergic reactions, and an increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 2 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

Progression-free survival (PFS) time

Secondary study objectives

Duration of response

Objective response

Overall survival (OS)

Other study objectives

CD20 expression

Dynamic molecular response of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) patients

Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) measurements

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Mosunetuzumab)Experimental Treatment7 Interventions

Patients receive mosunetuzumab SC on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience PD will be permitted to crossover to arm II at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.

Group II: Arm II (Rituximab, Rituximab and hyaluronidase human)Active Control8 Interventions

Patients receive rituximab IV on day 1 and rituximab and hyaluronidase human SC on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 2 cycles 8 weeks apart in the absence of disease progression or unacceptable toxicity. Patients may receive rituximab IV on days 8, 15, and 22 of each cycle if rituximab and hyaluronidase human is not available. Patients who experience PD will be permitted to crossover to arm I at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mosunetuzumab

2019

Completed Phase 2

~140

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Computed Tomography

2017

Completed Phase 2

~2790

Positron Emission Tomography

2011

Completed Phase 2

~2200

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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

Common treatments for Hodgkin's Lymphoma, such as mosunetuzumab and rituximab, are monoclonal antibodies that target the CD20 protein on B cells. These treatments work by binding to CD20, which is present on the surface of both normal and malignant B cells, marking them for destruction by the immune system. This mechanism is crucial for Hodgkin's Lymphoma patients because it helps the immune system specifically target and kill cancerous cells, potentially leading to improved survival rates and better disease management.