RecruitingPhase 1NCT05983965

Study of Tazemetostat in Lymphoid Malignancies

Phase I Study to Evaluate Safety and Tolerability of Tazemetostat in Relapsed/Refractory Peripheral T-cell Lymphoma


Sponsor

University of Alabama at Birmingham

Enrollment

30 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

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 treatment option. We propose a study to evaluate the safety of tazemetostat in relapsed / refractory peripheral T-cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tazemetostat, a targeted drug that blocks a specific cancer-related enzyme (EZH2), in people with peripheral T-cell lymphoma (a rare type of blood cancer) that has returned or stopped responding to previous treatment. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of peripheral T-cell lymphoma (one of the specific subtypes listed in the trial) - Your cancer has relapsed or is refractory (didn't respond to prior treatment) - You have received at least one prior treatment for your lymphoma - You have at least one measurable tumor on imaging **You may NOT be eligible if:** - You have not previously been treated for your lymphoma - You have uncontrolled active infections, including uncontrolled HIV or hepatitis C that hasn't been adequately treated - You are pregnant or breastfeeding - You have serious organ dysfunction that makes treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTazemetostat

Treatment: On day 1 and day 15 of the first cycle, and day 1 of all following cycles, the subject will have office visit with physical exam, vital signs, and lab tests. The subject will take tazemetostat twice a day by mouth continuously as an outpatient. If continuing on the treatment for more than 6 cycles, visits change to every 3 months.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT05983965


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