A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma
Memorial Sloan Kettering Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Screening Cohort (non-MSK patients only) 1. Age ≥18 years at time of consent 2. Has freely given written informed consent to participate in the study Treatment Cohort: 1. 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. 2. Age ≥18 years at time of enrollment 3. Previous systemic anti-cancer therapy for AITL must have been discontinued at least 2 weeks or 5 half-lives (whic…
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
- 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