A Phase II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein in Patients with Cutaneous T Cell Lymphoma (FDA IND Number: 100712).
Ronald P. Rapini
The goal of this clinical research study is to learn the safety and efficacy of AdmDT390-bisFv (UCHT1) in patients with cutaneous T-cell lymphoma.
Treatment Location: N/A
Primary: Evaluate the overall clinical responses including response rate and duration in a larger CTCL high-response patient population to see if is higher than current therapies (>49%). Determine the complete response rate and duration of response of A-dmDT390-bisFv(UCHT1) fusion protein in a larger CTCL high-response patient population to see if is higher than current therapies (>20%). Further define toxicities of A-dmDT390-bisFv(UCHT1) regimen in patients with CD3+ T-cell malignant diseases who have been selected to be free from preexisting cardiac disease. Determine if correlations exist between disease stage, tumor burden, anti-DT titer and degree of T cell depletion and response rate and response duration. Endpoints: Clinical response rate. Primary Toxicity profile. Duration of response-defined as time of first response to time of progression. Anti-A-dmDT390-bisFv (UCHT1) antibody titer, pretreatment and day 23. T cell depletion on day 5 or day 4 relative to the pretreatment value determined by flow cytometry of CD3+ cells in the lymphocyte gate and the measurement of the absolute lymphocyte count by CBC.
IRB Review and Approval Date: 09/24/2008
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase I/Phase II
Ronald P. Rapini
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