E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT01401530 |
Recruitment Status
:
Completed
First Posted
: July 25, 2011
Last Update Posted
: February 8, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral T-Cell Lymphoma | Biological: denileukin diftitox (E7777) | Phase 1 |
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 |

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

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

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): NCT01401530
Japan | |
Nagoya, Aichi, Japan | |
Kashiwa, Chiba, Japan | |
Isehara, Kanagawa, Japan | |
Chuo-ku, Tokyo, Japan |
Study Director: | Tadashi Nakanishi | Eisai Co., Ltd. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eisai Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01401530 History of Changes |
Other Study ID Numbers: |
E7777-J081-101 |
First Posted: | July 25, 2011 Key Record Dates |
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 |