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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc. ( Eisai Co., Ltd. )

ClinicalTrials.gov Identifier:

NCT01401530

First received: July 18, 2011

Last updated: February 5, 2016

Last verified: February 2016

History of Changes

Purpose

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	Intervention	Phase
Peripheral T-Cell Lymphoma	Biological: denileukin diftitox (E7777)	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Denileukin diftitox

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Peripheral T-cell Lymphoma

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Maximum Tolerated Dose (MTD) [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]


Enrollment:	13
Study Start Date:	July 2011
Study Completion Date:	January 2016
Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	20 Years to 79 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401530

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


Responsible Party:	Eisai Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01401530 History of Changes
Other Study ID Numbers:	E7777-J081-101
Study First Received:	July 18, 2011
Last Updated:	February 5, 2016
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:


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

ClinicalTrials.gov processed this record on September 23, 2016

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