A Phase 2 Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma

Eisai Co., Ltd.2 sites in 1 country45 target enrollmentMarch 28, 2016

ConditionsPeripheral T-cell Lymphoma Cutaneous T-cell Lymphoma

InterventionsE7777

DrugsE7777

Overview

Phase: Phase 2
Intervention: E7777
Conditions: Peripheral T-cell Lymphoma
Sponsor: Eisai Co., Ltd.
Enrollment: 45
Locations: 2
Primary Endpoint: Objective Response Rate (ORR)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).

Detailed Description

This is a multicenter, single-arm, open label, Phase 2 to evaluate efficacy, safety, pharmacokinetics and immunogenicity of E7777 in participants with relapsed or refractory PTCL and CTCL.

Registry

clinicaltrials.gov

Start Date

March 28, 2016

End Date

April 26, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
•Participant who have measurable disease.
•Participant who had previous systemic chemotherapy.
•Participant who had disease progression (PD) or did not have response (complete response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or progressed after systemic chemotherapy.
•Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or
•Participant with adequate renal, liver and bone marrow function.
•Male and female participants ≥20 years of age at the time of informed consent.
•Participants who have provided written consent to participate in the study.

Exclusion Criteria

•Participant with serious complications or histories.
•Participant with history of hypersensitivity to protein therapeutics.
•Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.
•Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.
•Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.
•Woman who is pregnant or lactating.
•Participant with allogeneic stem cell transplantation.
•Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.

Arms & Interventions

E7777

Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) will receive 9 μg/kg/day of E7777, administered by intravenous drip infusion in 60 minutes (± 10 min) for Days 1 through 5 of each cycle in maximum of 8 cycles. Every cycle consists of 3 weeks.

Intervention: E7777

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month

ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.

Secondary Outcomes

Duration of Response (DOR)(From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month)
Progression Free Survival (PFS)(From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month)
Time to Response (TTR)(From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR or death due to any cause (whichever occurred first) up to approximately 3 years 1 month)
CR Rate(From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month)
Overall Survival (OS)(From date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month))
Cmax: Maximum Observed Serum Concentration for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Tmax: Time to Reach the Cmax for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Mean Residence Time (MRT) for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
t1/2: Terminal Elimination Phase Half-life for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
CL: Total Clearance for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Vz: Volume of Distribution at Terminal Phase for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Vss: Volume of Distribution at Steady State for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Rac (Cmax): Accumulation Ratio of Cmax for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Rac (AUC): Accumulation Ratio of AUC for E7777(Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks))
Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies(Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks))
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody(Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks))