Study of Tazemetostat in Lymphoid Malignancies

Phase 1

Not yet recruiting

• Conditions: T-cell Lymphoma
• Interventions: Drug: Tazemetostat

• Registration Number: NCT05983965
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative t...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Start: 2024-09
• Primary Completion: 2028-07
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A	Tazemetostat	T-cell Lymphomas

Primary Outcome Measures

Name	Time	Method
Identify the recommended phase II dose of Tazemetostat	28 days	The measurement will be the occurrence of a dose limiting toxicity (DLT) in the first cycle (28 days) after treatment initiation from the start of cycle 1 day 1.; Measurements will be graded on a Hematologic Toxicity scale from grades 1 through 4 with grade 4 being worst grade.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States