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Monoclonal Antibodies

Rituximab vs Mosunetuzumab for Follicular Lymphoma

Phase 3

Recruiting

Led By Nilanjan Ghosh

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

Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern with large tumor in the inguinal region: Absence of IGH:BCL2 fusion, frequent STAT6 mutations along with 1p36 deletion or TNFRSF14 mutation

Participants must not have active autoimmune disease requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial compares two drugs, rituximab and mosunetuzumab, in treating patients with low tumor burden follicular lymphoma. Rituximab targets a protein found on B

Who is the study for?

This trial is for people with a confirmed diagnosis of classic follicular lymphoma without 'blastoid' features or grade 3B. They should have a low tumor burden, meaning no more than 3 large tumors and none bigger than 7 cm. Participants must not have severe symptoms, spleen enlargement, organ compression issues, or fluid buildup due to the cancer.

What is being tested?

The trial compares rituximab (a monoclonal antibody targeting CD20 on B cells) with mosunetuzumab (another monoclonal antibody that may stop cancer cells from growing). It's unclear which treatment is better for patients with low tumor burden follicular lymphoma.

What are the potential side effects?

Potential side effects include immune system reactions like fever and chills, infections due to lowered white blood cell counts, infusion-related reactions such as rash or difficulty breathing, and possible damage to healthy organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My follicular lymphoma has specific genetic features and lacks common mutations.

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I do not have an active autoimmune disease that needs treatment.

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I have not had a stem cell transplant from a donor.

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I am HIV positive, on effective treatment, and my last viral load was undetectable.

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I have never had macrophage activation syndrome or hemophagocytic lymphohistiocytosis.

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My lymphoma diagnosis is confirmed and matches specific criteria.

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My follicular lymphoma is in early stages with small tumors and no major symptoms.

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My hepatitis B is under control with undetectable viral load on recent tests.

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I have not had an organ transplant that requires me to take ongoing immunosuppressive drugs.

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I have never been diagnosed with progressive multifocal leukoencephalopathy.

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I had hepatitis C but am cured, or if currently treated, my latest test shows no virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Event free survival (EFS)

Incidence of adverse events

Overall survival

Other study objectives

PFS hazard ratios

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (Mosunetuzumab)Experimental Treatment4 Interventions

Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up.

Group II: Arm I (Rituximab, rituximab and hyaluronidase)Experimental Treatment5 Interventions

Patients receive rituximab IV on day 1 of cycle 1 and receive rituximab and hyaluronidase SC on days 8, 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles. Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Computed Tomography

2017

Completed Phase 2

~2790