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 ]

Objective Response Rate is defined as the proportion of subjects with best response of complete response (CR) or partial response (PR) using the Global Response Score of the consensus International Society for Cutaneous Lymphomas/ European Organization of Research and Treatment of Cancer (ISCL/EORTC) criteria.


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