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Monoclonal Antibodies
Tazemetostat + Mosunetuzumab for Follicular Lymphoma
Phase 2
Recruiting
Led By Samuel Yamshon, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for a maximum of approximately 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the safety and effectiveness of tazemetostat pills combined with mosunetuzumab injections to treat people with follicular lymphoma who haven't received treatment before.
Who is the study for?
This trial is for adults with untreated follicular lymphoma (Grades 1-3a) who can follow the study plan and are willing to use effective birth control. People with a history of certain blood cancers, severe infections like Hepatitis B/C or HIV, significant heart or lung disease, recent major surgery, CNS diseases, pregnancy, organ transplants, allergic reactions to monoclonal antibodies or active autoimmune diseases cannot join.
What is being tested?
The trial tests tazemetostat pills combined with mosunetuzumab injections in patients who haven't had prior treatments for follicular lymphoma. Tazemetostat targets an enzyme linked to lymphoma growth while mosunetuzumab directs the immune system against cancer cells. Their combination effectiveness and safety are under evaluation.
What are the potential side effects?
Potential side effects include reactions related to the immune system's activation such as fever and fatigue; digestive issues; liver problems; risk of infection due to lowered immunity; possible infusion-related reactions from injections; and other symptoms that may vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for a maximum of approximately 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a maximum of approximately 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who achieve a complete response (CR) by completion of therapy, as determined by the Lugano Criteria
Secondary study objectives
Median Duration of Response
Median Overall Survival (OS)
Median Progression-Free Survival (PFS)
+4 moreAwards & 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: Subcutaneous Mosunetuzumab and Oral TazemetostatExperimental Treatment2 Interventions
50 patients will be enrolled and treated with standard dosing of subcutaneous mosunetuzumab, and with oral tazemetostat by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation.
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?
Weill Medical College of Cornell UniversityLead Sponsor
1,086 Previous Clinical Trials
1,147,297 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,384 Total Patients Enrolled
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,790 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My slow-growing lymphoma has changed into a more aggressive type.I have or had brain lymphoma or cancer spread to the lining of my brain and spinal cord.I have had an organ transplant.I am HIV positive with a CD4 count below 200 and not on antiretroviral therapy.I have had a stem cell transplant from a donor.I do not have severe heart or lung disease.I have had cancer treatment for lymphoma before, but not excluded if it was radiation.I have had a blood disorder like MDS, AML, or MPN in the past.I am currently being treated for an autoimmune disease.I haven't had a stroke, brain bleed, seizures, or neurodegenerative disease in the last 3 months.I have a significant history of liver disease.I have a history of autoimmune disease.I cannot take pills or have a condition that affects how my body absorbs medication.My condition is Grade 3b Follicular Lymphoma.I have a history of T cell lymphoblastic lymphoma or leukemia.I have or might have a long-term active Epstein-Barr virus infection.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I have not had any drug treatments for lymphoma, only local radiation if any.I have or might have had HLH in the past.I do not have an active Hepatitis B or C infection.I haven't had major surgery in the last 28 days and don't expect any during the study.I have never had progressive multifocal leukoencephalopathy.I have been diagnosed with a type of lymphoma called follicular lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Subcutaneous Mosunetuzumab and Oral Tazemetostat
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.
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