Clinical Trial: A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma
Brief Summary: 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.
Detailed Summary: This is a multicenter, open-label, single-arm study of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL). The study will consist of an initial lead-in phase (in which a dose of E7777 will be selected), followed by the Main Study. Participants will move through three phases while on study: Pretreatment Phase, Treatment Phase, and Extension Phase and a Follow-up Period.
Sponsor: Eisai Inc.
Current Primary Outcome:
- Dose-limiting toxicities (DLTs) in the Lead-in Part of the Study [ Time Frame: Cycle 1 (21 days) ]
- Maximum Tolerated Dose (MTD) in the Lead-in Part of the Study [ Time Frame: Up to12 months ]
- Objective Response Rate (ORR) in the Main Phase of Study [ Time Frame: Day 1 until disease progression/recurrence, or up to 30 months ]
Original Primary Outcome: Objective Response Rate (ORR) [ Time Frame: 36 months ]
Current Secondary Outcome:
- Duration of Response (DOR) [ Time Frame: Day 1 until disease progression/recurrence, or up to 12 months (Lead-in) and Day 1 until disease progression/recurrence, or up to 30 months (Main Phase) ]
- Time to Response (TTR) [ Time Frame: Up to 12 months (Lead-in) and up to 30 months (Main Phase ) ]
- Objective Response Rate (ORR) [ Time Frame: Day 1 until disease progression/recurrence, up to 12 months (Lead-in) and Day 1 until disease progression/recurrence, up to 30 months (by using Prince (2010) criteria in Main Phase) ]
- Number of Participants with Any Adverse Event and Any Serious Adverse Event (SAE) [ Time Frame: From first dose of the study drug until 30 days after the last dose, or up to 30 months ]
- Maximum Drug Concentration (Cmax) [ Time Frame: Day 1 of Cycles 1, 3, 5,and 8 (Lead-in) and Day 1 of Cycles 1, 3, 5, and 8 for the first 12 participants and Day 1 of Cycle 1 for all other participants (Main Phase) ]Blood samples will be collected at pre-dose; 30 minutes (min) after the start of the infusion; at the end of the infusion; and 30, 60, 90, 120, 180, 240, and 300 min postinfusion stop. Sparse samples will be collected at pre-dose, at the end of the infusion, and between 60 and 180 min postinfusion.
- Area Under the Curve from Time 0 to Time t (AUC[0-t]) [ Time Frame: Day 1 of Cycles 1, 3, 5,and 8 (Lead-in) and Day 1 of Cycles 1, 3, 5, and 8 for the first 12 participants and Day 1 of Cycle 1 for all other participants (Main Phase) ]Blood samples will be collected at pre-dose; 30 minutes (min) after the start of the infusion; at the end of the infusion; and 30, 60, 90, 120, 180, 240, and 300 min postinfusion stop. Sparse samples will be collected at pre-dose, at the end of the infusion, and between 60 and 180 min postinfusion.
- Area Under the Curve from Time 0 to Time Infinity (AUC[0-inf]) [ Time Frame: Day 1 of Cycles 1, 3, 5,and 8 (Lead-in) and Day 1 of Cycles 1, 3, 5, and 8 for the first 12 participants and Day 1 of Cycle 1 for all other participants (Main Phase) ]Blood samples will be collected at pre-dose; 30 minutes (min) after the start of the infusion; at the end of the infusion; and 30, 60, 90, 120, 180, 240, and 300 min postinfusion stop. Sparse samples will be collected at pre-dose, at the end of the infusion, and between 60 and 180 min postinfusion.
- Terminal Elimination Half-life (t1/2) [ Time Frame: Day 1 of Cycles 1, 3, 5,and 8 (Lead-in) and Day 1 of Cycles 1, 3, 5, and 8 for the first 12 participants and Day 1 of Cycle 1 for all other participants (Main Phase) ]Blood samples will be collected at pre-dose; 30 minutes (min) after the start of the infusion; at the end of the infusion; and 30, 60, 90, 120, 180, 240, and 300 min postinfusion stop. Sparse samples will be collected at pre-dose, at the end of the infusion, and between 60 and 180 min postinfusion.
- Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies [ Time Frame: Baseline; 10. Day 1 of Cycles 1, 2, 3, 5, and 8 (for Anti-E7777 and Anti-IL-2); Anti-IL-2 is to be tested at 6 month and thereafter every year until antibody levels decrease to baseline levels ]
Original Secondary Outcome:
Information By: Eisai Inc.
Dates:
Date Received: March 28, 2013
Date Started: May 9, 2016
Date Completion: June 30, 2019
Last Updated: May 11, 2017
Last Verified: April 2017