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

Launched by EISAI CO., LTD. · Jul 21, 2011

Keywords

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Gender

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Eligibility 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