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Monoclonal Antibodies
Tazemetostat for Follicular Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Epizyme, Inc.
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 planned to be assessed from earliest date of cr or pr to documented progression or death as assessed up to 24 months by an irc
Awards & highlights
Study Summary
This trial looks at whether a new combination of drugs is safe and effective in treating people with a certain type of cancer who have not responded to other treatments.
Eligible Conditions
- Follicular Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ planned to be assessed from earliest date of cr or pr to documented progression or death as assessed up to 24 months by an irc
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~planned to be assessed from earliest date of cr or pr to documented progression or death as assessed up to 24 months by an irc
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
ORR in Rituximab Refractory Participants
ORR in a Subset of Participants With MT EZH2
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tazmetostat in combination with rituximabExperimental Treatment2 Interventions
Tazemetostat 800 mg BID is administered daily starting on Cycle 1 Day 1 (C1D1). Tazemetostat will be administered from C1D1 to the end of Cycle 24, for 24 months of therapy or until disease progression, unacceptable toxicity, or withdrawal of consent. Rituximab will be administered by either subcutaneous injection or IV infusion according to the regional product prescribing information, labeling and institutional guidelines. Rituximab will be administered at a dose of 375 mg/m2 on Day 1, 8, 15, and 22 of Cycle 1, and then on Day 1 of Cycles 3 through 6, accounting for an additional 4 doses, i.e., a total of 8 doses of rituximab in 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Hyaluronidase
FDA approved
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,849 Total Patients Enrolled
Swedish Cancer InstituteUNKNOWN
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
55,140 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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