Status:
COMPLETED
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Peripheral T-Cell Lymphoma
Eligibility:
All Genders
20-79 years
Phase:
PHASE1
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 cuta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01401530
Start Date
July 1 2011
End Date
January 1 2016
Last Update
November 23 2018
Active Locations (4)
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1
Nagoya, Aichi-ken, Japan
2
Kashiwa, Chiba, Japan
3
Isehara, Kanagawa, Japan
4
Chuo-ku, Tokyo, Japan