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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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of study registration through end of follow-up, approximately 5 years.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My blood counts meet the required levels, not due to lymphoma.
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My tumor is causing symptoms or affecting how my organs work.
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I have lymphoma and meet specific criteria indicating I need treatment.
Select...
I can take care of myself and perform daily activities.
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I have B-cell lymphoma and have only used corticosteroids for symptom relief.
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My spleen is enlarged and causing symptoms.
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I have a mass larger than 7 cm, not including the spleen.
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I agree to follow the safety program rules for using lenalidomide.
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I have at least 3 large nodes, each bigger than 3 cm.
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I am 18 years or older and can give informed consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of study registration through end of follow-up, approximately 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of study registration through end of follow-up, approximately 5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate
Secondary outcome measures
Progression Free Survival
Side effects data
From 2021 Phase 1 trial • 23 Patients • NCT0431360841%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Rash
6%
Upper respiratory tract infection
6%
Cytomegalovirus infection reactivation
6%
Thrombosis
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx
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
~1480
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,091 Total Patients Enrolled
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,292 Total Patients Enrolled
Adam OlszewskiLead Sponsor
2 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts meet the required levels, not due to lymphoma.I have no cancer history that could interfere with this study, or if I do, it's been in remission for over 2 years.I have severe heart issues, including recent heart attack or unstable heart rhythm.My tumor is causing symptoms or affecting how my organs work.I do not have active infections or certain viral conditions.I don't have any current infections or recent major infections that required IV antibiotics or hospitalization.I do not have active brain conditions except well-controlled issues as specified.I have had a stem cell or organ transplant in the past.I have a confirmed diagnosis of follicular or marginal zone lymphoma.I do not have any major health or mental issues that would stop me from following the study rules.I can take care of myself and perform daily activities.I agree to use birth control during and for 3 months after the trial.I have lymphoma and meet specific criteria indicating I need treatment.I do not have a history of serious autoimmune diseases, except for controlled thyroid issues, asthma, type 1 diabetes, Sjögren syndrome, or mild skin conditions.I haven't taken strong immune system medications recently, except for low-dose steroids.You are willing to sign a paper saying you understand what the study is about and agree to follow its rules.My lymphoma is confirmed to be a specific type and tests positive for CD20.I have not received a live vaccine within the last 4 weeks and do not plan to during the study.I do not have significant liver problems like hepatitis, alcohol abuse, or cirrhosis.I am not pregnant, breastfeeding, or a prisoner. I can take a pregnancy test before and during treatment.My condition is Grade 3b follicular lymphoma or transformed lymphoma.I have a tumor that can be measured and is larger than specified sizes.I have B-cell lymphoma and have only used corticosteroids for symptom relief.My spleen is enlarged and causing symptoms.I agree to give my lymphoma tissue for further study if it's available.I have a mass larger than 7 cm, not including the spleen.I agree to follow the safety program rules for using lenalidomide.I have at least 3 large nodes, each bigger than 3 cm.I haven't had major surgery in the last 4 weeks, except for a lymph node biopsy.I haven't had radiation therapy in the last 2 weeks.I have previously been treated with an anti-CD20 antibody or lenalidomide.I need oral steroids or oxygen for my COPD.I am 18 years or older and can give informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: Planned Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open enrolment opportunities for this research initiative?
"As per the information posted on clinicaltrials.gov, this trial is actively seeking patient participants. It was initially published on July 14th 2022 and has been recently amended as of November 17th 2022."
Answered by AI
How many participants are actively engaged in this clinical experiment?
"Genentech, Inc. is seeking a total of 52 participants that meet the criteria for this trial and will be operating it out of two sites: Rutgers Cancer Institute in New jersey and Yale Cancer Center in Connecticut."
Answered by AI
Could you enlighten me on any other experiments involving Mosunetuzumab?
"Mosunetuzumab was first studied at Saint Joseph Regional Medical Center-Mishawaka in 2004; since then, 347 clinical trials have been concluded. Currently 277 are actively recruiting participants, many based out of New Brunswick, New jersey."
Answered by AI
To what extent might Mosunetuzumab be hazardous to patients?
"Mosunetuzumab's safety is rated at a 2, as the Phase 2 trial indicates this drug has some evidence of being safe but none demonstrating its efficacy."
Answered by AI
What medical applications has Mosunetuzumab been utilized for?
"Mosunetuzumab is a frequently employed treatment for multiple myeloma and other refractory lymphomas, chronic lymphocytic leukemia, and conditions requiring two prior systemic chemotherapy regimens."
Answered by AI
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