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

Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

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.

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