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Anti-tumor antibiotic
Tazemetostat + Rituximab + Bendamustine for Follicular Lymphoma
Phase 1 & 2
Recruiting
Led By Vaishalee Kenkre, MD
Research Sponsored by Vaishalee Kenkre
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug combo of tazemetostat, bendamustine and rituximab to treat cancer. Patients get the drugs on a 28-day cycle for up to 3 cycles.
Who is the study for?
Adults with high tumor burden follicular lymphoma, grades 1-2 or 3A, who haven't had certain prior treatments can join. They must have good organ function and no history of severe heart disease, active infections, other cancers in the last 3 years (with some exceptions), CNS metastases, uncontrolled HIV/AIDS or hepatitis C.
What is being tested?
The trial tests Tazemetostat combined with Bendamustine and Rituximab for untreated high-burden follicular lymphoma. It's a two-phase study where all patients get these drugs in cycles: first three cycles include all three drugs; next three just Tazemetostat and Rituximab.
What are the potential side effects?
Possible side effects include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. Liver or kidney issues might occur due to drug interactions affecting organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I: Evaluate safety and tolerability of tazemetostat with bendamustine and rituximab (BR)
Phase II: Complete metabolic response (CMR) with 3 cycles of BR + tazemetostat followed by 3 cycles of rituximab + tazemetostat
Secondary study objectives
Complete Metabolic Response (CMR) after 3 cycles BR + tazemetostat
Duration of Response (DOR)
Heart rate
Awards & 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: Investigational GroupExperimental Treatment3 Interventions
Phase 1:
90 mg/m\^2 of bendamustine by IV on Day 1 and 2 of a 28 day cycle (up to 3 Cycles)
375 mg/m\^2 of rituximab by IV on Day 1 of a 28 day cycle (up to 3 Cycles)
Participants enrolled in this phase will be given one of 3 different dose levels of tazemetostat along with the drugs above (for up to 3 Cycles). 3 patients will be assigned to the lowest dose level and if the dose is tolerated, 3 more patients will be enrolled one dose level higher. Up to 18 participants being enrolled.
Dose Level 1: 400 mg of tazemetostat orally twice daily
Dose Level 2: 600 mg of tazemetostat orally twice daily
Dose Level 3: 800 mg of tazemetostat orally twice daily
Phase 2:
6 patients from Phase 1 who were treated at the recommended Phase 2 dose will be added to 21 additional patients.
375 mg/m\^2 of rituximab through IV on Day 1 of a 28 day cycle (Cycles 1-6)
Tazemetostat orally twice daily of a 28 day cycle (Cycles 1-6)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~3230
Tazemetostat
2016
Completed Phase 2
~1050
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
Vaishalee KenkreLead Sponsor
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,798 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,231 Previous Clinical Trials
3,199,843 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active brain metastases or leptomeningeal disease.I do not have an active infection needing treatment within 4 weeks of starting the study drug.I have been diagnosed with hepatitis C.I have HIV that is not currently under control.I am 18 years old or older.I have been active and mostly self-sufficient in the last 10 days.I do not have serious heart disease or heart failure.My cancer is at stage II, III, or IV according to the Ann Arbor system.I have had EZH2 testing or can provide tissue for it.I've only had radiation, rituximab, or steroids for symptoms in the last 28 days.I have a detectable cancer site on PET scan.My recent tests show my organs are functioning well.I am currently on medication for a serious infection.I haven't had cancer that could affect this treatment's safety or results in the last 3 years.I haven't taken strong medication that affects liver enzymes in the last 28 days.My follicular lymphoma is considered high burden or high risk.My lymphoma is low grade (not grade 3B) and hasn't transformed.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Group
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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