A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, T-Cell, Cutaneous
Both
Lymphoma, T-Cell, Cutaneous
Trial Information
A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma
Inclusion Criteria:
Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell
lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one
and no more than 3 systemic treatments.
Exclusion Criteria:
Patients with visceral involvement, serious infection or illness including human
immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be
excluded.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
Outcome Time Frame:
24 weeks
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
C014
NCT ID:
NCT00043420
Start Date:
January 2003
Completion Date:
March 2007
Related Keywords:
- Lymphoma, T-Cell, Cutaneous
- immunotherapy, lymphoma
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
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