Description:

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

Link:

http://clinicaltrials.gov/ct2/show/record/NCT00050999

Keywords:
Versions (3) ▾
  1. 11/14/11
  2. 3/23/14
  3. 4/11/14
Uploaded on:

April 11, 2014

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY 4.0
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00050999 T-Cell Lymphoma

Details

Eligibility NCT00050999

  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).
Back to the top of the page