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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Complete Metabolic Response (CMR) after 3 cycles BR + tazemetostat
Duration of Response (DOR)
Heart rate

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
~2950
Rituximab
1999
Completed Phase 4
~1880
Tazemetostat
2016
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Vaishalee KenkreLead Sponsor
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,884 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,184 Previous Clinical Trials
3,169,426 Total Patients Enrolled

Media Library

Bendamustine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05551936 — Phase 1 & 2
Follicular Lymphoma Research Study Groups: Investigational Group
Follicular Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT05551936 — Phase 1 & 2
Bendamustine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551936 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of participants enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is still recruiting volunteers since it was first posted on January 26th 2023 and last updated on February 8th 2023. It requires 42 patients at a single research centre."

Answered by AI

Are there any vacancies available for participants in this experiment?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical trial has been open for recruitment since January 26th and was last updated on February 8th 2023. The study requires 42 participants to be enrolled from a single site."

Answered by AI
~0 spots leftby May 2024