Clinical trial NCT06756308: A Study of Enasidenib in People With T-Cell Lymphoma
Official title: A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: T-cell Lymphoma
Keywords: Enasidenib
Rituximab
IDH2-mutant
23-269
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: The Leukemia and Lymphoma Society
First posted: 2025-01-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: response rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute (Data Collection Only)
state: Massachusetts
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: