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Monoclonal Antibodies
Mosunetuzumab for Follicular Lymphoma
Phase 2
Recruiting
Led By Lorenzo Falchi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Adequate hepatic function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test whether mosunetuzumab is an effective treatment for newly diagnosed follicular lymphoma patients who have not yet received any treatments for their disease.
Who is the study for?
Adults with newly diagnosed, untreated Follicular Lymphoma (FL) grades 1, 2, or 3A are eligible for this trial. They must have measurable disease and be fit for chemoimmunotherapy. Key requirements include good liver and bone marrow function, no severe heart or lung conditions, no active infections or other cancers within the last two years. Participants need to agree to biopsies and use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The study is testing Mosunetuzumab's effectiveness in treating Follicular Lymphoma that hasn't been treated before. It aims to determine whether this drug can help patients with FL by assessing its impact on their cancer.See study design
What are the potential side effects?
While not explicitly listed in the provided information, similar drugs often cause side effects like infusion reactions (fever/chills), fatigue, weakness, nausea/vomiting/diarrhea; low blood cell counts leading to increased infection risk; possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My liver is working well.
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My cancer is at an advanced stage but not the earliest or final stages.
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I can take care of myself and am up and about more than half of my waking hours.
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My bone marrow is working well.
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My diagnosis is untreated Follicular Lymphoma of grade 1, 2, or 3A.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Complete Respons/CR
Secondary outcome measures
Overall Response Rate/ORR
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: Participants with newly diagnosed Follicular LymphomaExperimental Treatment1 Intervention
Participants with newly diagnosed FL in need of systemic therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,822 Total Patients Enrolled
Lorenzo Falchi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a solid organ transplant.I am 18 years old or older.My liver is working well.I need treatment that affects my whole body.I have hepatitis C.I am currently undergoing or have completed radiation therapy.I have or had lymphoma in my brain or spinal cord.I have had a stem cell transplant from a donor.My cancer is at an advanced stage but not the earliest or final stages.I have been diagnosed with PML in the past.I have or had a serious brain or spinal cord disease.I am currently taking medication that weakens my immune system.My condition is either Follicular Lymphoma grade 3B or transformed Follicular Lymphoma.I do not have any serious medical conditions or abnormal lab test results.I have received treatment for lymphoma before.I have a serious heart condition.I have had cancer before.I can take care of myself and am up and about more than half of my waking hours.I have or might have had HLH in the past.I have not received any live vaccines recently.I currently have an active infection.I have a serious lung condition.My bone marrow is working well.My diagnosis is untreated Follicular Lymphoma of grade 1, 2, or 3A.I am not a candidate for combined chemotherapy and immunotherapy.My follicular lymphoma is only in one area outside of the lymph nodes.I am not eligible for systemic therapy.My condition is pediatric follicular lymphoma.I have had major surgery recently.I have an ongoing Epstein-Barr Virus infection.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with newly diagnosed Follicular Lymphoma
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.
How many participants are involved in this clinical research study?
"Affirmative. According to clinicaltrials.gov, this ongoing medical trial requires the recruitment of 53 participants from 8 different sites - it was initially published on May 27th 2022 and has recently been updated on November 9th 2022."
Answered by AI
Has Mosunetuzumab been granted authorization from the Food and Drug Administration?
"There is a moderate amount of safety data associated with Mosunetuzumab, leading to it being accorded a score of 2 on our team's scale. Unfortunately, no evidence exists yet that this drug can be effective in treating any conditions."
Answered by AI
Are recruitment efforts for this study still ongoing?
"Confirmed. According to clinicaltrials.gov, this research is currently onboarding participants since its inception on May 27th 2022 and latest update November 9th 2022. It requires 53 people from 8 distinct medical locales for completion of the study."
Answered by AI
How many sites have been appointed to oversee the trial?
"8 sites are offering this clinical trial, situated in Rochester, Middletown and Rockville Centre amongst other places. It is suggested that participants choose the most proximate clinic to decrease commute times if they decide to take part."
Answered by AI
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