A Study of Enasidenib in People With T-Cell Lymphoma (NCT06756308) | Clinical Trial Compass
RecruitingPhase 2
A Study of Enasidenib in People With T-Cell Lymphoma
United States25 participantsStarted 2024-12-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at time of consent
✓. Has freely given written informed consent to participate in the study
✓. 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.
✓. 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.
Exclusion criteria
✕. 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): 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
✕. Measurable disease, defined by either of:
✕. 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)
✕. Women must agree to not breastfeed during the study period
✕. Male subjects must agree to practice true abstinence from sexual intercourse or to the use of highly effective contraceptive methods with non-pregnant female partners of childbearing potential at screening and throughout the course of the study, and should avoid conception with their partners during the course of the study and for 4 months following the last study treatment
✕0. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
✕. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.