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

Eisai Co., Ltd.45 enrolled

Overview

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).

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral T-cell Lymphoma Cutaneous T-cell Lymphoma

Interventions

E7777DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). 2. Participant who have measurable disease. 3. Participant who had previous systemic chemotherapy. 4. 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. 5. Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 6. Participant with adequate renal, liver and bone marrow function. 7. Male and female participants ≥20 years of age at the time of informed consent. 8. Participants who have provided written consent to participate in the study. Exclusion Criteria: 1. Participant with serious complications or histories. 2. Participant with history of hypersensitivity to protein therapeutics. 3. Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen. 4. Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent. 5. Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception. 6. Woman who is pregnant or lactating. 7. Participant with allogeneic stem cell transplantation. 8. Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.

Locations (20)

Eisai Trial Site #1

Nagoya, Aichi-ken, Japan

Eisai Trial Site #2

Nagoya, Aichi-ken, Japan

Eisai Trial Site #1

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

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.

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

Secondary Outcomes

Progression Free Survival (PFS)

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.

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

Duration of Response (DOR)

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.

Data from ClinicalTrials.gov

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Kashiwa, Chiba, Japan

Eisai Trial Site #1

Ōta, Gunma, Japan

Eisai Trial Site #1

Kobe, Hyōgo, Japan

Eisai Trial Site #1

Tsukuba, Ibaraki, Japan

Eisai Trial Site #1

Isehara, Kanagawa, Japan

Eisai Trial Site #1

Sendai, Miyagi, Japan

Eisai Trial Site #1

Kurashiki, Okayama-ken, Japan

Eisai Trial Site #1

Suita, Osaka, Japan

...and 10 more locations

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

Time to Response (TTR)

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.

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

CR Rate

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.

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

Overall Survival (OS)

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.

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

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)

Cmax: Maximum Observed Serum Concentration for E7777