Phase
Condition
Lymphoproliferative Disorders
Lymphoma
T-cell Lymphoma
Treatment
Enasidenib
Rituximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2mutation (by MSK ddPCR). For R/R patients, disease must have relapsed or progressedafter 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 AITLmust 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 adjuvantand maintenance therapy for prior malignancy. Patients who have received localizedRT as part of their immediate prior therapy may be allowed to enroll with shorterwashout period after discussion with the MSKCC Principal Investigator ii) Patientswho have received localized RT as part of their immediate prior therapy may beallowed to enroll with shorter washout period after discussion with the MSKCCPrincipal Investigator iii) Systemic corticosteroids must be tapered to 25 mg/dayprednisone (or equivalent) upon start of investigational treatment iv) 4) 5) 6) 7)
- Topical steroids for treating cutaneous involvement of AITL is permittedPerformance status, as assessed in the ECOG grading system, ≤2 Laboratory criteria (use of GCSF and/or blood product transfusions to reach eligibility criteria must bediscussed with the MSK PI on a case-by-case basis):
Exclusion
Exclusion Criteria:
Study Design
Connect with a study center
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts 02115
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (Limited protocol activities)
Uniondale, New York 11553
United StatesActive - Recruiting
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