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

Eisai

Status and phase

Completed

Phase 4

Conditions

Mycosis Fungoides

Sezary Syndrome

Lymphoma, T-Cell, Cutaneous

Treatments

Drug: ONTAK

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051012

93-04-14

Details and patient eligibility

About

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.