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

Eisai

Status and phase: Completed; Phase 1

Conditions: Peripheral T-Cell Lymphoma

Treatments: Biological: denileukin diftitox (E7777)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01401530

E7777-J081-101

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

E7777

Experimental group

Treatment:

Biological: denileukin diftitox (E7777)