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

Launched by EISAI INC. · Jan 2, 2003

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • CTCL disease Stage Ia - III.
• • History of less than or equal to 3 previous 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 chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
• • Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
• • No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
• • No systemic infections.
• • ECOG performance status of 0 or 1.
• Exclusion Criteria:
• • • The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.