Investigational Group for Follicular Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Wisconsin Carbone Cancer Center, Madison, WIFollicular LymphomaBendamustine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Follicular Lymphoma

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 2 years

2 years
Complete Metabolic Response (CMR) after 3 cycles BR + tazemetostat
Duration of Response (DOR)
Heart rate
Phase II: Complete metabolic response (CMR) with 3 cycles of BR + tazemetostat followed by 3 cycles of rituximab + tazemetostat
6 months
Phase I: Evaluate safety and tolerability of tazemetostat with bendamustine and rituximab (BR)

Trial Safety

Trial Design

1 Treatment Group

Investigational Group
1 of 1

Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: Investigational Group · No Placebo Group · Phase 1 & 2

Investigational GroupExperimental Group · 3 Interventions: Bendamustine, Rituximab, Tazemetostat · Intervention Types: Drug, Drug, Drug
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
~760

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Vaishalee KenkreLead Sponsor
Epizyme, Inc.Industry Sponsor
30 Previous Clinical Trials
2,873 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,078 Previous Clinical Trials
2,584,210 Total Patients Enrolled
Vaishalee Kenkre, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18+ · All Participants · 33 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to meet at least one of the following GELF Criteria:
You are experiencing general symptoms like fever, unexplained weight loss, and night sweats.
Your spleen is enlarged.
You are at risk of compression in certain areas of your body, such as the spinal cord or urinary tract.
I'm sorry, but that criterion is incomplete. Can you provide more information on what it entails?

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.