Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Inclusion Criteria
lnclusion Criteria:
- Male and female patients 20 to <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