A Study of Enasidenib in People With T-Cell Lymphoma (NCT06756308)

🧪 Interventions in This Study

• Enasidenib (DRUG)
• Rituximab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Screening Cohort (non-MSK patients only)
2. Age ≥18 years at time of consent
3. Has freely given written informed consent to participate in the study Treatment Cohort:
4. Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2 mutation (by MSK ddPCR). For R/R patients, disease must have relapsed or progressed after at least one systemic therapy, diagnostic tumor samples have at least 5% tumor.
5. Age ≥18 years at time of enrollment
6. Previous systemic anti-cancer therapy for AITL must have been discontinued at least 2 weeks or 5 half-lives (whichever is longer) prior to treatment. i) See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy. ii) Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSKCC Principal Investigator iii) Systemic corticosteroids must be tapered to 25 mg/day prednisone (or equivalent) upon start of investigational treatment iv) Topical steroids for treating cutaneous involvement of AITL is permitted
7. Performance status, as assessed in the ECOG grading system, ≤2
8. Laboratory criteria (use of GCSF and/or blood product transfusions to reach eligibility criteria must be discussed with the MSK PI on a case-by-case basis): i) Absolute neutrophil count ≥1.0 K/μL or ≥0.5 K/μL if due to lymphoma ii) Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma iii) Calculated creatinine clearance ≥30 mL/min by the Modification of Diet in Renal Disease (MDRD) glomerular filtration rate iv) Total bilirubin ≤1.5x upper limit of normal (ULN) or ≤3x ULN if documented hepatic involvement with lymphoma, or ≤5x ULN if history of Gilbert's syndrome; AST and ALT ≤ 3x ULN; ≤ 5x ULN if due to lymphoma involvement
9. Measurable disease, defined by either of:
10. Revised International Working Group Classification for systemic lymphoma(13)
11. Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
12. Women of reproductive potential\* must have a negative serum or urine β human chorionic gonadotropin (β-hCG) pregnancy test. All women of reproductive potential must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug. \*A woman of reproductive potential is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
• Memorial Sloan Kettering Cancer Center (Limited Protocol Activities) — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
• Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York
• Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York
• Memorial Sloan Kettering Nassau (Limited protocol activities) — Uniondale, New York

📞 Contact the Study Coordinator

Phone: (800) 525-2225

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in T-cell Lymphoma

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• Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma — New Haven, Connecticut
• A Registry for People With T-cell Lymphoma — Duarte, California
• Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma — Columbus, Ohio
• A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma — Palo Alto, California

Explore by condition: All T-cell Lymphoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.