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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
Must not have
Prior solid organ transplantation
Acute or chronic HCV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing mosunetuzumab, a drug that helps the immune system fight cancer, in people newly diagnosed with follicular lymphoma.
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.
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.
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.
Select...
My diagnosis is untreated Follicular Lymphoma of grade 1, 2, or 3A.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a solid organ transplant.
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I have hepatitis C.
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I have or had lymphoma in my brain or spinal cord.
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I have had a stem cell transplant from a donor.
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I have been diagnosed with PML in the past.
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I have or had a serious brain or spinal cord disease.
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I am currently taking medication that weakens my immune system.
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My condition is either Follicular Lymphoma grade 3B or transformed Follicular Lymphoma.
Select...
I do not have any serious medical conditions or abnormal lab test results.
Select...
I have received treatment for lymphoma before.
Select...
I have a serious heart condition.
Select...
I have had cancer before.
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I have or might have had HLH in the past.
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I have not received any live vaccines recently.
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I currently have an active infection.
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I have a serious lung condition.
Select...
My follicular lymphoma is only in one area outside of the lymph nodes.
Select...
I am not eligible for systemic therapy.
Select...
I have an ongoing Epstein-Barr Virus infection.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Complete Respons/CR
Secondary study objectives
Overall Response Rate/ORR
Side effects data
From 2021 Phase 1 trial • 23 Patients • NCT0431360841%
Cytokine release syndrome
35%
Anaemia
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
24%
Platelet count decreased
24%
Fatigue
24%
Neutropenia
24%
Hypophosphataemia
24%
Nausea
24%
Liver function test abnormal
24%
Constipation
24%
Thrombocytopenia
18%
Oral candidiasis
18%
Lethargy
18%
Arthralgia
18%
Weight decreased
18%
Neutrophil count decreased
18%
Hypokalaemia
18%
Sepsis
18%
Headache
18%
Peripheral sensory neuropathy
12%
Paraesthesia
12%
Vomiting
12%
Superficial vein thrombosis
12%
Rectal haemorrhage
12%
Flushing
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Pain in extremity
12%
Gastrooesophageal reflux disease
12%
Colitis
12%
Abdominal discomfort
12%
Dizziness
6%
Photosensitivity reaction
6%
Adenocarcinoma
6%
Dyspnoea exertional
6%
Wound infection
6%
Chest pain
6%
Gamma-glutamyltransferase increased
6%
Orthostatic hypotension
6%
Cellulitis
6%
Hypogammaglobulinaemia
6%
External ear cellulitis
6%
Tumour lysis syndrome
6%
Vasospasm
6%
Upper respiratory tract infection
6%
Abdominal distension
6%
Urinary tract infection
6%
Transient ischaemic attack
6%
Hypertension
6%
Blood creatinine increased
6%
Abdominal tenderness
6%
Seasonal allergy
6%
Injury
6%
Hypoalbuminaemia
6%
Performance status decreased
6%
Hyperlipidaemia
6%
Hyperglycaemia
6%
Epistaxis
6%
Oropharyngeal pain
6%
Intention tremor
6%
Hypocalcaemia
6%
Decreased appetite
6%
Back pain
6%
Throat irritation
6%
Rash
6%
Thrombosis
6%
Rash maculo-papular
6%
Cytomegalovirus infection reactivation
6%
Squamous cell carcinoma
6%
Depression
6%
Neutropenic sepsis
6%
Vision blurred
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Aspartate aminotransferase increased
6%
Groin pain
6%
Pain in jaw
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single Agent MosunetuzumabExperimental Treatment1 Intervention
Participants with newly diagnosed FL in need of systemic therapy
Group II: Mosunetuzumab + ZanubrutinibExperimental Treatment2 Interventions
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
Zanubrutinib
2017
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,445 Total Patients Enrolled
156 Trials studying Lymphoma
9,193 Patients Enrolled for Lymphoma
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: Single Agent Mosunetuzumab
- Group 2: Mosunetuzumab + Zanubrutinib
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.