← Back to Search

Monoclonal Antibodies

Mosunetuzumab + Lenalidomide for Lymphoma

Phase 2
Recruiting
Led By Adam J Olszewski, MD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly): hemoglobin ≥9 g/dL, absolute neutrophil count ≥1.0 x 109/L, platelet count ≥75 x 109/L.
local symptoms or compromise of normal organ function due to tumor mass;
Must not have
Known NYHA class 3/4 congestive heart failure, LVEF <40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the first dose of mosunetuzumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of study registration through end of follow-up, approximately 5 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for lymphoma that involves using mosunetuzumab alone for four cycles, followed by an assessment of response. If the patient responds well, they will continue treatment with mosunetuzumab. If the patient does not respond well, they will receive mosunetuzumab with lenalidomide augmentation during the next four cycles.

Who is the study for?
Adults over 18 with untreated Follicular Lymphoma or Marginal Zone Lymphoma, who can provide tissue samples and consent to study procedures. They must have measurable lymphoma lesions, agree to contraception requirements, and enroll in the lenalidomide REMS program. Excluded are those with severe allergies, certain heart conditions, recent major surgery or infections, liver disease, pregnancy/breastfeeding status, other cancers affecting compliance or results.
What is being tested?
The trial tests mosunetuzumab alone for four cycles followed by an interim response assessment (IRA). Depending on IRA results (complete response or partial response), patients may continue with mosunetuzumab alone or receive it augmented with lenalidomide for another four cycles. The primary response is assessed after eight cycles.
What are the potential side effects?
Potential side effects include allergic reactions to monoclonal antibodies; infection risks due to immunosuppression; liver issues from lenalidomide; blood disorders like anemia and low platelet counts; fatigue; digestive problems; and possible impact on fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood counts meet the required levels, not due to lymphoma.
Select...
My tumor is causing symptoms or affecting how my organs work.
Select...
I have lymphoma and meet specific criteria indicating I need treatment.
Select...
I can take care of myself and perform daily activities.
Select...
I have B-cell lymphoma and have only used corticosteroids for symptom relief.
Select...
My spleen is enlarged and causing symptoms.
Select...
I have a mass larger than 7 cm, not including the spleen.
Select...
I agree to follow the safety program rules for using lenalidomide.
Select...
I have at least 3 large nodes, each bigger than 3 cm.
Select...
I am 18 years or older and can give informed consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe heart issues, including recent heart attack or unstable heart rhythm.
Select...
I don't have any current infections or recent major infections that required IV antibiotics or hospitalization.
Select...
I have had a stem cell or organ transplant in the past.
Select...
I do not have significant liver problems like hepatitis, alcohol abuse, or cirrhosis.
Select...
I am not pregnant, breastfeeding, or a prisoner. I can take a pregnancy test before and during treatment.
Select...
My condition is Grade 3b follicular lymphoma or transformed lymphoma.
Select...
I haven't had major surgery in the last 4 weeks, except for a lymph node biopsy.
Select...
I haven't had radiation therapy in the last 2 weeks.
Select...
I have previously been treated with an anti-CD20 antibody or lenalidomide.
Select...
I need oral steroids or oxygen for my COPD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of study registration through end of follow-up, approximately 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of study registration through end of follow-up, approximately 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 Rate
Secondary study objectives
Progression Free Survival

Side effects data

From 2023 Phase 1 & 2 trial • 117 Patients • NCT03677141
67%
Anaemia
67%
Thrombocytopenia
67%
Diarrhoea
67%
Oedema peripheral
67%
Fall
67%
Platelet count decreased
67%
Decreased appetite
67%
Hypomagnesaemia
67%
Neuropathy peripheral
33%
Supraventricular tachycardia
33%
Pneumocystis jirovecii pneumonia
33%
Sepsis
33%
Malignant neoplasm progression
33%
Hypotension
33%
Neutropenia
33%
Abdominal pain
33%
Nausea
33%
Oral pain
33%
Stomatitis
33%
Vomiting
33%
Fatigue
33%
Influenza
33%
Weight decreased
33%
White blood cell count decreased
33%
Hypokalaemia
33%
Hyponatraemia
33%
Taste disorder
33%
Confusional state
33%
Acute kidney injury
33%
Cough
33%
Hiccups
33%
Alopecia
33%
Dry skin
33%
Nail disorder
33%
Rash
33%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group A1: Phase Ib Mosunetuzumab + CHOP
Group A2: Phase Ib Mosunetuzumab + CHOP
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Group C: Phase II Mosunetuzumab + CHOP
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)

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: Planned TherapyExperimental Treatment2 Interventions
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

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,004 Total Patients Enrolled
Brown UniversityLead Sponsor
466 Previous Clinical Trials
699,028 Total Patients Enrolled
Adam OlszewskiLead Sponsor
2 Previous Clinical Trials
31 Total Patients Enrolled
Adam J Olszewski, MDPrincipal InvestigatorBrown University
2 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Mosunetuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04792502 — Phase 2
Follicular Lymphoma Research Study Groups: Planned Therapy
Follicular Lymphoma Clinical Trial 2023: Mosunetuzumab Highlights & Side Effects. Trial Name: NCT04792502 — Phase 2
Mosunetuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04792502 — Phase 2
~10 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top