RecruitingPhase 2NCT06756308

A Study of Enasidenib in People With T-Cell Lymphoma

A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

25 participants

Start Date

Dec 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study to find out whether enasidenib is a safe treatment for people with angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. The researchers will look at the safety of enasidenib when it is given alone or in combination with the drug rituximab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing enasidenib, a targeted drug, in people with a rare type of T-cell lymphoma called angioimmunoblastic T-cell lymphoma (AITL) that has a specific gene mutation (IDH2). The drug targets this mutation and may help shrink or control the cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AITL confirmed by biopsy with an IDH2 mutation - Your cancer has returned or did not respond to at least one prior treatment - You are in reasonably good health (able to care for yourself) **You may NOT be eligible if...** - You have a serious medical condition, abnormal lab results, or active uncontrolled infection - You are currently on immune-suppressing therapy after a stem cell transplant - You are pregnant or breastfeeding - You have chronic liver disease or active hepatitis B or C - You have previously used enasidenib - You have HIV with a detectable viral load or low CD4 count 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

DRUGEnasidenib

Enasidenib 100 mg daily on 28-day cycles.

DRUGRituximab

IV rituximab 375 mg/m² weekly for the first month, and monthly thereafter on 28-day cycles, for a total of four months of rituximab.


Locations(8)

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06756308


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