E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Eisai Inc.
Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01401530
First received: July 18, 2011
Last updated: December 15, 2014
Last verified: October 2014
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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:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | March 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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401530
Contacts
| Contact: Customer Joy Department, EJ | 81-120-161-454 |
Locations
| Japan | |
| Recruiting | |
| Nagoya, Aichi, Japan | |
| Recruiting | |
| Kashiwa, Chiba, Japan | |
| Recruiting | |
| Isehara, Kanagawa, Japan | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan | |
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
| Study Director: | Tadashi Nakanishi | Eisai Co., Ltd. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( 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: | December 15, 2014 |
| 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 Immune System Diseases Immunoproliferative Disorders |
Lymphatic Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on March 01, 2015