A Study of Enasidenib in People With T-Cell Lymphoma

Last updated: December 27, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoproliferative Disorders

Lymphoma

T-cell Lymphoma

Treatment

Enasidenib

Rituximab

Clinical Study ID

NCT06756308
23-269
  • Ages > 18
  • All Genders

Study 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

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)

    1. 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

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Enasidenib
Phase: 2
Study Start date:
December 24, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Dana Farber Cancer Institute (Data Collection Only)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All protocol activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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