Description:

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00050999

Link:
http://clinicaltrials.gov/ct2/show/record/NCT00050999
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Versions (3)
  1. 11/14/11 11/14/11 -
  2. 3/23/14 3/23/14 - Martin Dugas
  3. 4/11/14 4/11/14 - Julian Varghese
Uploaded on:

April 11, 2014

DOI:
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Creative Commons BY 4.0
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Eligibility NCT00050999 T-Cell Lymphoma

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Eligibility NCT00050999

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility NCT00050999
Inclusion criteria
18 Years and older
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).
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