E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.

Condition or disease	Intervention/treatment	Phase
Peripheral T-Cell Lymphoma	Biological: denileukin diftitox (E7777)	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	13 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Study Start Date :	July 2011
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	January 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: E7777	Biological: denileukin diftitox (E7777); E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.

Outcome Measures

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Primary Outcome Measures :

1. Maximum Tolerated Dose (MTD) [ Time Frame: 3 Weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

lnclusion Criteria:

• Male and female patients 20 to less than 80 years of age at the time of informed consent
• Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma
• Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in relapse, recurrence and treatment resistance (just for the administration of E7777 alone)
• Patients subject to CHOP therapy and without a history of prior treatment with anthracycline or anthraquinone anticancer drugs (just for the administration of E7777 in combination with CHOP therapy)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• No carry-over of beneficial or adverse effects of the prior treatment that may affect the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and alopecia)

Exclusion Criteria:

Brain metastasis with clinical symptoms which requires treatment

Serious systemic infection requiring intensive treatment

Serious complications or histories

History of hypersensitivity to protein therapeutics

Known to be positive for HIV antibody, HCV antibody, or HBs antigen

History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission

Patients who have undergone allogeneic hematopoietic stem cell transplantation

Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Isehara, Kanagawa, Japan
Chuo-ku, Tokyo, Japan

Sponsors and Collaborators

Eisai Co., Ltd.

Investigators

Study Director:	Tadashi Nakanishi	Eisai Co., Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ohmachi K, Ando K, Ogura M, Uchida T, Tobinai K, Maruyama D, Namiki M, Nakanishi T. E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma: A phase I study. Cancer Sci. 2018 Mar;109(3):794-802. doi: 10.1111/cas.13513. Epub 2018 Feb 26.

Responsible Party:	Eisai Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01401530 History of Changes
Other Study ID Numbers:	E7777-J081-101
First Posted:	July 25, 2011
Last Update Posted:	February 8, 2016
Last Verified:	February 2016

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):

Neoplasms; Neoplasms by Histologic Type; Lymphoma; Non-Hodgkin; T- Cell	Lymphatic Diseases; Lymphoproliferative Disorders; lmmune System Diseases; lmmunoproliferative Disorders

Additional relevant MeSH terms:

Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders	Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Denileukin diftitox; Antineoplastic Agents