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

Launched by EISAI INC. · Jan 2, 2003

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
• • Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
• • Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
• • Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
• • Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
• • No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
• • No systemic infections;
• • Willingness to be randomized to a placebo treatment only arm;
• • ECOG performance status 0 or 1;
• Exclusion Criteria:
• • • Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).