Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI-1)
CTCL
Item
Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
boolean
C0079773 (UMLS CUI-1)
Prior CTCL therapy
Item
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
boolean
C0039798 (UMLS CUI-1)
C0079773 (UMLS CUI-2)
Interleukin-2 receptor expression
Item
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
boolean
C0034819 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
Disease stage
Item
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.
boolean
C0699749 (UMLS CUI-1)
Other diseases
Item
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
boolean
C2359476 (UMLS CUI-1)
Willingness
Item
Willingness to be randomized to a placebo treatment only arm
boolean
C1516879 (UMLS CUI-1)
C0599724 (UMLS CUI-2)
Item
ECOG performance status 0 or 1
text
C1520224 (UMLS CUI-1)
Code List
ECOG performance status 0 or 1
Previous trials
Item
Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
boolean
C2348568 (UMLS CUI-1)