Study on Enasidenib for Treating T-Cell Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT06756308
This clinical trial is exploring whether the drug enasidenib is safe for treating people with a specific type of T-cell lymphoma called angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. The study will test enasidenib alone and in combination with another drug, rituximab.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if enasidenib is a safe treatment option for individuals with angioimmunoblastic T-cell lymphoma (AITL) that has a specific genetic change known as an IDH2 mutation. Researchers will evaluate the safety of enasidenib when used by itself or together with the drug rituximab.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of angioimmunoblastic T-cell lymphoma (AITL) with an IDH2 mutation.
- For patients whose disease has returned or worsened, it must have happened after at least one previous treatment.
- Tumor samples must show at least 5% tumor cells.
- Must be 18 years or older.
- Previous cancer treatments must have been stopped at least two weeks before starting the study treatment.
- If you received localized radiation therapy as your last treatment, you might be able to join the study sooner after discussing with the study doctor.
- Must be able to reduce steroid use to 25 mg/day of prednisone (or equivalent) when starting the study treatment.
- Topical steroids for skin involvement of AITL are allowed.
- Must have a performance status score of 2 or less, meaning you are able to carry out all self-care but unable to carry out any work activities.
- Must meet specific laboratory criteria, which may involve discussions with the study doctor if you need growth factors or blood transfusions to qualify.
Exclusion Criteria
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute (Data Collection Only) | 02115 | Boston | Massachusetts |
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Cancer Center (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited protocol activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (All protocol activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Nassau (Limited protocol activities) | 11553 | Uniondale | New York |
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