ID
4181
Description
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients 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
Keywords
Versions (1)
- 11/10/13 11/10/13 - Martin Dugas
Uploaded on
November 10, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00051012 T-Cell Lymphoma
Eligibility
- StudyEvent: Eligibility
Description
Exclusion criteria
Description
Medical Concepts
Description
Enrollment
Data type
string
Alias
- UMLS CUI
- C1516879
Description
Diagnosis
Data type
string
Alias
- UMLS CUI
- C0011900
Description
Diagnostic Neoplasm Staging
Data type
string
Alias
- UMLS CUI
- C0027646
Description
Therapeutic procedure
Data type
string
Alias
- UMLS CUI
- C0087111
Description
Pharmaceutical Preparations
Data type
string
Alias
- UMLS CUI
- C0013227
Description
ECOG performance status finding
Data type
string
Alias
- UMLS CUI
- C1828127
- SNOMED CT 2010_0731
- 424122007
Similar models
Eligibility
- StudyEvent: Eligibility
424122007 (SNOMED CT 2010_0731)