Expired Study
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Houston, Texas 77030


Purpose:

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.


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.


NCT ID:

NCT00051012


Primary Contact:

Study Director
Elyane Lombardy, M.D.
Ligand Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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