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Immunomodulatory Agents

Mosunetuzumab + Lenalidomide vs Rituximab for Follicular Lymphoma (Celestimo Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Histologically documented CD20+ FL (Grades 1-3a)

Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy

Must not have

History of solid organ transplantation

Active or history of CNS lymphoma or leptomeningeal infiltration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two treatments for people with a certain type of blood cancer who have tried other treatments unsuccessfully.

Who is the study for?

This trial is for adults with relapsed or refractory follicular lymphoma who have had at least one prior systemic therapy. They must be in a condition to receive treatment, not have grade 3b FL or transformed indolent disease, and no recent exposure to certain cancer therapies. Participants need adequate organ function and cannot be pregnant, breastfeeding, or planning pregnancy; they must agree to contraception measures.

What is being tested?

The study compares the effectiveness of mosunetuzumab combined with lenalidomide versus rituximab combined with lenalidomide in treating follicular lymphoma. It will assess which combination works better for those who've already tried other treatments.

What are the potential side effects?

Potential side effects include allergic reactions to monoclonal antibodies, infusion-related reactions, blood disorders, increased risk of infections due to immunosuppression from medications like tocilizumab and lenalidomide. Organ-specific inflammation may also occur.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is CD20 positive and is grade 1-3a.

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I have had treatment for lymphoma that included immunotherapy or chemoimmunotherapy.

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I can provide a biopsy sample or have one from my latest relapse for my FL diagnosis.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a solid organ transplant.

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I have or had brain lymphoma or cancer spread to the lining of my brain and spinal cord.

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I have or might have a long-term active Epstein-Barr virus infection.

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I have or might have had a condition where my immune system attacks my body.

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My slow-growing lymphoma has changed into an aggressive type.

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I have had a stem cell transplant from a donor.

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I have an active Hepatitis C infection.

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I am allergic to certain medications made in specific lab cells or their ingredients.

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I have a history of lung conditions like interstitial lung disease or pneumonitis.

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I have never had progressive multifocal leukoencephalopathy.

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I haven't had major surgery in the last 28 days and don't expect any during the study.

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I don't have major side effects from previous treatments, except for hair loss.

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I've had severe skin reactions or blisters from past immune therapy.

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I do not have any major health issues that could interfere with the study.

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I have an active Hepatitis B infection.

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I am HIV positive.

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I do not have any other cancer that could interfere with this study.

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I haven't taken strong immune system suppressing drugs in the last 2 weeks.

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I cannot take blood clot prevention medications due to health reasons.

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I am currently being treated for an autoimmune disease.

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I have a significant history of liver disease.

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My condition is Grade 3b Follicular Lymphoma.

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

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

3Treatment groups

Experimental Treatment

Group I: R + Len (Arm B)Experimental Treatment3 Interventions

Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)

Group II: M + Len (US Extension Arm C)Experimental Treatment3 Interventions

Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)

Group III: M + Len (Arm A)Experimental Treatment3 Interventions

Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mosunetuzumab

2019

Completed Phase 2

~140

Lenalidomide

2005

Completed Phase 3

~2240