A Study of Enasidenib in People With T-Cell Lymphoma

Phase 2

Recruiting

• Conditions: T-cell Lymphoma
• Interventions: Drug: Enasidenib; Drug: Rituximab

• Registration Number: NCT06756308
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-24
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-02
• Last Update Posted: 2025-01-02
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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. i) IDH2 hotspot mutation confirmed by CAP/CLIA-certified NGS testing panel. Only cases with confirmed mutations detected >1% VAF will be eligible.

• Age ≥18 years at time of enrollment 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) ii) See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy. 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 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) 4) 5) 6) 7) 8) 9) Topical steroids for treating cutaneous involvement of AITL is permitted Performance status, as assessed in the ECOG grading system, ≤2 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):

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enasidenib and rituximab	Enasidenib	All patients will receive oral enasidenib 100 mg daily on 28-day cycles. Patients with evidence of a co-occuring B-cell LPB will also received IV rituximab 375 mg/m² weekly for the first month, and monthly thereafter (four total months of rituximab provided no evidence of active EBV or B-cell lymphoproliferation)) on 28-day cycles. Treatment may continue until volitional patient withdrawal, disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Enasidenib and rituximab	Rituximab	All patients will receive oral enasidenib 100 mg daily on 28-day cycles. Patients with evidence of a co-occuring B-cell LPB will also received IV rituximab 375 mg/m² weekly for the first month, and monthly thereafter (four total months of rituximab provided no evidence of active EBV or B-cell lymphoproliferation)) on 28-day cycles. Treatment may continue until volitional patient withdrawal, disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

Primary Outcome Measures

Name	Time	Method
response rate	1 year	a 20% response rate is undesirable and 45% is desirable

Trial Locations

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