Expired Study
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Houston, Texas 77030


Purpose:

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.


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).


NCT ID:

NCT00050999


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 10, 2017

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