Mycosis Fungoides Clinical Trial
Official title:
Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (Resimmune®) in Subjects With Mycosis Fungoides: A Phase II Multi-center Randomized Clinical Trial
This study evaluates the effectiveness — as judged by complete response — of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.
Primary Objective: This study objective is to document the incidence of complete responses
compared to oral vorinostat, in a randomized 2-arm trial after a maximum of 12 months of
treatment for subjects with stage IB/IIB mycosis fungoides with mSWAT < 50 who have never
had lymphoid disease or a prior bone marrow / HSCT transplant.
Secondary Objective: To further explore the toxicity profile of A-dmDT390-bisFv(UCHT1)
fusion protein for subjects with mycosis fungoides who have been selected to be free from
preexisting cardiac disease and never treated with Campath.
Number of Subjects: Lead-in Dosing: 12 / Randomized: 162
Patients will receive full supportive care during the course of the study. Participation in
the study will require IV infusions of the research agent 2 times a day for four days
(protocol FDA outpatient approved), as well as frequent outpatient blood draws for the first
30 days. Patients with partial or complete remissions at their 1 month follow up visit will
have another follow-up visit on day 60, then every three months for 1 year, followed by
annual visits to assess duration of the response.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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