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    Association details:
    Biomarker:IL2RA expression
    Cancer:Cutaneous T-cell Lymphoma
    Drug:Ontak (denileukin diftitox) (IL-2 stimulant)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    Ontak is a CD25-directed cytotoxin indicated for the treatment of adult patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

    Excerpt:
    ...- Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry....
    Trial ID:
    NCT00050999
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients

    Excerpt:
    ...- Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells....
    Trial ID:
    NCT00051012
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Sci
    Title:

    Phase 2 study of E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma

    Published date:
    03/31/2021
    Excerpt:
    Among the 36 patients with PTCL and CTCL, objective response rate based on the independent review was 36% (41% in PTCL, and 31% in CTCL). The median progression-free survival was 3.1 months (2.1 months in PTCL and 4.2 months in CTCL). Our results indicated that a 9 µg/kg/day dose of E7777 shows efficacy and a manageable safety profile in Japanese patients with relapsed or refractory PTCL and CTCL, with clinical activity observed across the range of CD25 expression.
    DOI:
    10.1111/cas.14906