- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676778
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
June 24, 2021 updated by: Eisai Co., Ltd.
A Phase 2 Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
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).
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
- Eisai Trial Site #1
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Kagoshima, Japan
- Eisai Trial Site #1
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Kyoto, Japan
- Eisai Trial Site #1
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Okayama, Japan
- Eisai Trial Site #1
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Aichi
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Nagoya, Aichi, Japan
- Eisai Trial Site #1
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Nagoya, Aichi, Japan
- Eisai Trial Site #2
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Chiba
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Kashiwa, Chiba, Japan
- Eisai Trial Site #1
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Gunma
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Ota, Gunma, Japan
- Eisai Trial Site #1
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Hyogo
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Kobe, Hyogo, Japan
- Eisai Trial Site #1
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Ibaraki
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Tsukuba, Ibaraki, Japan
- Eisai Trial Site #1
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Kanagawa
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Isehara, Kanagawa, Japan
- Eisai Trial Site #1
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Miyagi
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Sendai, Miyagi, Japan
- Eisai Trial Site #1
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Okayama
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Kurashiki, Okayama, Japan
- Eisai Trial Site #1
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Osaka
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Suita, Osaka, Japan
- Eisai Trial Site #1
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Suita, Osaka, Japan
- Eisai Trial Site #2
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Shizuoka
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Hamamatsu, Shizuoka, Japan
- Eisai Trial Site #1
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Tamagata
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Yamagata, Tamagata, Japan
- Eisai Trial Site #1
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Tokyo
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Bunkyo-ku, Tokyo, Japan
- Eisai Trial Site #1
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Chuo-ku, Tokyo, Japan
- Eisai Trial Site #1
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Koto-ku, Tokyo, Japan
- Eisai Trial Site #1
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 1.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression Free Survival (PFS)
Time Frame: 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
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PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011).
PD: Any new lesion or unequivocally increase of previously involved sites from nadir.
PFS was calculated using Kaplan-Meier method.
Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored.
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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
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Duration of Response (DOR)
Time Frame: 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
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DOR: Time between date of first documentation of CR or PR and PD or death due to any cause based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on revised response criteria for malignant lymphoma (Cheson,2007),skin lesion and peripheral blood disease by clinical end points and response criteria in mycosis fungoides and Sezary syndrome(Olsen,2011). DOR was assessed in responders who had CR or PR.
CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
PD: Any new lesion or unequivocally increase of previously involved sites from nadir.
DOR was calculated using Kaplan-Meier method.
Participants with new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored.
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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
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Time to Response (TTR)
Time Frame: 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
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TTR was defined as time between the date of administration of the first dose of the study drug and the date of first documentation PR or CR based on independent review of Efficacy and Safety Evaluation Committee.
PR or CR were 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).
TTR was only conducted among responders who had experienced CR or PR.
CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
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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
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CR Rate
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
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CR rate was defined as the percentage of participants whose BOR was CR based on independent review of Efficacy and Safety Evaluation Committee.
CR 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.
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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
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Overall Survival (OS)
Time Frame: 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
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OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause.
Participants who were alive at cut-off were censored.
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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
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: 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)
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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)
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Cmax: Maximum Observed Serum Concentration for E7777
Time Frame: 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)
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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)
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Tmax: Time to Reach the Cmax for E7777
Time Frame: 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)
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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)
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AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777
Time Frame: 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)
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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)
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AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777
Time Frame: 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)
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11 participants were included in the PK analysis, however AUC(0-inf), could not be estimated for 1 participant due to insufficient data for elimination rate constant.
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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)
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Mean Residence Time (MRT) for E7777
Time Frame: 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)
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11 participants were included in the PK analysis, however MRT, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
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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)
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t1/2: Terminal Elimination Phase Half-life for E7777
Time Frame: 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)
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11 participants were included in the PK analysis, however t1/2, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
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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)
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CL: Total Clearance for E7777
Time Frame: 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)
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11 participants were included in the PK analysis, however CL, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
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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)
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Vz: Volume of Distribution at Terminal Phase for E7777
Time Frame: 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)
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11 participants were included in the PK analysis, however Vz, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
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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)
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Vss: Volume of Distribution at Steady State for E7777
Time Frame: 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)
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11 participants were included in the PK analysis, however Vss, could not be estimated for 1 participant due to insufficient data for elimination rate constant.
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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)
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Rac (Cmax): Accumulation Ratio of Cmax for E7777
Time Frame: 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)
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Accumulation Ratio of Cmax was calculated as RAC (Cmax) on Cycle 3 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1, and RAC (Cmax) on Cycle 5 Day 1 divided by RAC (Cmax) on Cycle 1 Day 1.
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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)
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Rac (AUC): Accumulation Ratio of AUC for E7777
Time Frame: 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)
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Accumulation ratio of AUC was calculated as RAC (AUC) on Cycle 3 Day 1 divided by RAC (AUC) on Cycle 1 Day 1, and RAC (AUC) on Cycle 5 Day 1 divided by RAC (AUC) on Cycle 1 Day 1.
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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)
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Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies
Time Frame: Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
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Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
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Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody
Time Frame: Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
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Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2016
Primary Completion (Actual)
April 26, 2019
Study Completion (Actual)
April 26, 2019
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
February 5, 2016
First Posted (Estimate)
February 8, 2016
Study Record Updates
Last Update Posted (Actual)
July 15, 2021
Last Update Submitted That Met QC Criteria
June 24, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7777-J081-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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