NCT02676778

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Typical duration for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

June 1, 2021

Enrollment Period

3.1 years

First QC Date

February 4, 2016

Results QC Date

June 24, 2021

Last Update Submit

June 24, 2021

Conditions

Peripheral T-cell LymphomaCutaneous T-cell Lymphoma

Keywords

Peripheral T-cell lymphomaCutaneous T-cell lymphomaE7777Phase 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 (19)

  • 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

  • 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

  • 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

  • +14 more secondary outcomes

Study Arms (1)

E7777

EXPERIMENTAL

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.

Drug: E7777

Interventions

E7777DRUG
E7777

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Eisai Trial Site #1

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site #2

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site #1

Kashiwa, Chiba, Japan

Location

Eisai Trial Site #1

Ōta, Gunma, Japan

Location

Eisai Trial Site #1

Kobe, Hyōgo, Japan

Location

Eisai Trial Site #1

Tsukuba, Ibaraki, Japan

Location

Eisai Trial Site #1

Isehara, Kanagawa, Japan

Location

Eisai Trial Site #1

Sendai, Miyagi, Japan

Location

Eisai Trial Site #1

Kurashiki, Okayama-ken, Japan

Location

Eisai Trial Site #1

Suita, Osaka, Japan

Location

Eisai Trial Site #2

Suita, Osaka, Japan

Location

Eisai Trial Site #1

Hamamatsu, Shizuoka, Japan

Location

Eisai Trial Site #1

Yamagata, Tamagata, Japan

Location

Eisai Trial Site #1

Bunkyo-ku, Tokyo, Japan

Location

Eisai Trial Site #1

Chuo-ku, Tokyo, Japan

Location

Eisai Trial Site #1

Koto-ku, Tokyo, Japan

Location

Eisai Trial Site #1

Fukuoka, Japan

Location

Eisai Trial Site #1

Kagoshima, Japan

Location

Eisai Trial Site #1

Kyoto, Japan

Location

Eisai Trial Site #1

Okayama, Japan

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, Cutaneous

Interventions

E7777 fusion protein

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Inquiry Service.
Organization
Eisai Co., Ltd.
eisai-chiken_hotline@hhc.eisai.co.jp

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 8, 2016

Study Start

March 28, 2016

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

July 15, 2021

Results First Posted

July 15, 2021

Record last verified: 2021-06

Locations

JP(20)