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Immunomodulatory agents

Mosunetuzumab + Lenalidomide for Follicular Lymphoma

Phase 1 & 2

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

Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)

At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)

Must not have

Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

Grade >=2 neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing mosunetuzumab + lenalidomide as a possible treatment for relapsed or refractory follicular lymphoma. Researchers will also compare the safety, efficacy, and immunogenicity of mosunetuzumab + len given intravenously versus subcutaneously.

Who is the study for?

This trial is for adults with follicular lymphoma who've had at least one prior treatment. They must be in stable condition, not have severe allergies to monoclonal antibodies or certain infections, and agree to contraception if of childbearing potential. Those with a history of certain other cancers or conditions are excluded.

What is being tested?

The study tests the combination of mosunetuzumab (given intravenously or subcutaneously) with lenalidomide in patients with follicular lymphoma. It aims to compare safety, how the body processes the drugs, and their effectiveness against this type of cancer.

What are the potential side effects?

Potential side effects include reactions related to infusion such as fever and chills, low blood cell counts increasing infection risk, tiredness, rash or itching at injection site for SC administration, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma shows up on PET scans.

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I have a tumor that can be measured by a PET-CT scan.

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My follicular lymphoma is Grade 1, 2, or 3a and CD20 positive.

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I have follicular lymphoma and have been treated before with systemic therapy.

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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 a significant history of liver problems.

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I experience significant numbness or pain in my hands or feet.

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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 cannot take blood clot prevention medications.

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I have a history of DLBCL or my condition has changed into DLBCL.

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I have active Hepatitis B or C, or an autoimmune disease needing treatment.

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

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My condition did not improve after treatment with obinutuzumab alone.

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

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

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I have had a stem cell transplant from a donor.

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

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I have a history of Grade 3b follicular lymphoma.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I am HIV positive.

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I have or might have a chronic Epstein-Barr virus infection or hemophagocytic syndrome.

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I have had progressive multifocal leukoencephalopathy.

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My blood counts are too low.

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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 a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I have a history of MAS or HLH.

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Any severe side effects from my past treatments have improved.

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I have had a solid organ transplant.

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I have had a stem cell transplant from a donor.

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.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized)Experimental Treatment2 Interventions

Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles.

Group II: Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized)Experimental Treatment3 Interventions

Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)

Group III: Arm B: SC Mosunetuzumab + Len (Randomized)Experimental Treatment2 Interventions

Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)

Group IV: Arm A: IV Mosunetuzumab + Len (Randomized)Experimental Treatment2 Interventions

Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Tocilizumab

2012

Completed Phase 4

~1840