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

Phase 1
20 Years
79 Years
Open (Enrolling)
Peripheral T-Cell Lymphoma

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Trial Information

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

- Patients with a history of chemotherapy (including PUVA and retinoid) that resulted
in relapse, recurrence and treatment resistance (just for the administration of E7777

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

3 Weeks

Safety Issue:


Principal Investigator

Tadashi Nakanishi

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

July 2011

Completion Date:

August 2013

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Neoplasms
  • Neoplasms by Histologic Type
  • Lymphoma
  • Non-Hodgkin
  • T- Cell
  • Lymphatic Diseases
  • Lymphoproliferative Disorders
  • lmmune System Diseases
  • lmmunoproliferative Disorders
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral