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A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma
The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in dose-finding part will be used to determine the dose of E7777 that should be used to test efficacy and safety.
STUDY OBJECTIVES LEAD-IN PART Primary Objectives: To establish the maximum tolerated dose (MTD) of E7777 and to select the dose of E7777 to be used in the Main Study. Secondary Objectives: To assess safety, tumor response, pharmacokinetics (PK), and immunogenicity after treatment with E7777. MAIN STUDY Primary Objective: To demonstrate efficacy of E7777 in subjects with recurrent or persistent CTCL as assessed by objective response rate (ORR; Objective Response is Complete Response [CR] and Partial Response [PR], according to ISCL/EORTC Global Response Score [Olsen 2011]). Secondary Objectives: To determine the efficacy endpoint of Duration of Response (DOR) for E7777. To determine time to response after E7777 treatment. To determine skin response after E7777 treatment. To determine duration of skin Response after E7777 treatment. To determine time to skin response after E7777 treatment. To assess objective response rate (ORR) for E7777 using the alternate response assessment criteria of Prince (2010)5. To evaluate safety and tolerability of E7777. To characterize the pharmacokinetics (PK) of E7777 and immunogenicity after treatment with E7777. Exploratory Objectives: To assess two efficacy endpoints for subjects treated with E7777: progression-free survival (PFS) and time to progression (TTP) (using Global Response Score). To assess pruritus improvement reported by subjects treated with E7777. To assess Quality of Life (QoL) for subjects treated with E7777.