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Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Follicular Lymphoma Clinical Trial

Official title:
Phase I Trial of Tazemetostat in Combination With Venetoclax in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

Clinical Trial Summary

The goal of this clinical trial is to learn about how a combination of tazemetostat and venetoclax in people with relapsed/refractory Non-Hodgkin Lymphoma (R/R NHL). The main questions that this trial aims to answer are what is the best dose of venetoclax to give with tazemetostat to people with R/R NHL; what types of side effects do people with R/R NHL get when taking venetoclax with tazemetostat; and what effects does this combination have on R/R NHL. Participants will need to take pills by mouth every day and regularly come to the clinic for blood work and imagining to monitor side effects and cancer progression. Participants may receive study drugs for up to 24 months.

Clinical Trial Description

This a phase 1, single arm, non-randomized trial of tazemetostat in combination with venetoclax in participants with two types of relapsed/refractory non-Hodgkin lymphoma. The purpose of this study is to evaluate the safety of the combination of tazemetostat and venetoclax in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL). This trial will be conducted in two parts. Part one will be a single-arm, open-label sequential dose escalation (3+3) of venetoclax in combination with a fixed dose of tazemetostat (800mg BID) to determine the maximum tolerated dose (MTD) of venetoclax. In part two, two expansion cohorts (R/R DLBCL and R/R FL) will be enrolled to further characterize the safety and tolerability of the combination, and to estimate the preliminary efficacy. Up to 18 participants will be enrolled in part 1 and 20 participants will be enrolled in part 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05618366
Study type Interventional
Source Weill Medical College of Cornell University
Contact Tejasvi Kaur Sahni
Phone 646-962-8189
Email tks4001@med.cornell.edu
Status Recruiting
Phase Phase 1
Start date June 7, 2023
Completion date December 2028
View Details
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