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

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ClinicalTrials.gov Identifier: NCT02676778
Recruitment Status : Active, not recruiting
First Posted : February 8, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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).

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Cutaneous T-cell Lymphoma Drug: E7777 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Actual Study Start Date : March 28, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
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.
Drug: E7777



Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From the date of beginning to the end of E7777 administration, or up to approximately 6 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From the date of beginning of E7777 administration to the date of first documentation of disease progression or death (whichever occurs first), or up to approximately 32 months ]
  2. Duration of Response (DOR) [ Time Frame: From the date of first documentation of response to the end of response due to E7777 administration, or up to approximately 32 months ]
  3. Time to Response (TTR) [ Time Frame: From the date of beginning of E7777 administration to the date of first document of response, or up to approximately 6 months ]
  4. Complete Response (CR) Rate [ Time Frame: From the date of beginning to the end of E7777 administration, or up to approximately 6 months ]
  5. Overall survival (OS) [ Time Frame: From the date of beginning of E7777 administration until date of death from any cause, or up to approximately 32 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676778


Locations
Japan
Eisai Trial Site #1
Nagoya, Aichi, Japan
Eisai Trial Site #2
Nagoya, Aichi, Japan
Eisai Trial Site #1
Kashiwa, Chiba, Japan
Eisai Trial Site #1
Ota, Gunma, Japan
Eisai Trial Site #1
Kobe, Hyogo, 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, Japan
Eisai Trial Site #1
Suita, Osaka, Japan
Eisai Trial Site #2
Suita, Osaka, Japan
Eisai Trial Site #1
Hamamatsu, Shizuoka, Japan
Eisai Trial Site #1
Yamagata, Tamagata, Japan
Eisai Trial Site #1
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site #1
Chuo-ku, Tokyo, Japan
Eisai Trial Site #1
Koto-ku, Tokyo, Japan
Eisai Trial Site #1
Fukuoka, Japan
Eisai Trial Site #1
Kagoshima, Japan
Eisai Trial Site #1
Kyoto, Japan
Eisai Trial Site #1
Okayama, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02676778     History of Changes
Other Study ID Numbers: E7777-J081-205
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: May 2018

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Peripheral T-cell lymphoma
Cutaneous T-cell lymphoma
E7777
Phase 2

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases