E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
NCT ID: NCT01401530
Last Updated: 2018-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2011-07-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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E7777
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.
Interventions
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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 Criteria
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Exclusion Criteria
* 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
20 Years
79 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tadashi Nakanishi
Role: STUDY_DIRECTOR
Eisai Co., Ltd.
Locations
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Nagoya, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Isehara, Kanagawa, Japan
Chuo-ku, Tokyo, Japan
Countries
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References
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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.
Other Identifiers
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E7777-J081-101
Identifier Type: -
Identifier Source: org_study_id
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