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

This study is currently recruiting participants.
Verified November 2012 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01401530
First received: July 18, 2011
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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, both in the treatment of E7777 alone and E7777 in combination with CHOP therapy (combination with cyclophosphamide, doxorubicin, vincristine and prednisolone) in patients with peripheral or cutaneous T-cell lymphoma.


Condition Intervention Phase
Peripheral T-Cell Lymphoma
 Biological: denileukin diftitox (E7777) alone and E7777 plus CHOP therapy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: denileukin diftitox (E7777) alone and E7777 plus CHOP therapy

E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 μg/kg/day to 12, 15 and then to 18 in a stepwise fashion.

E7777 will be administrated by IV infusion on Day 1 and 2 of each cycle (21 days/cycle) for E7777 combination therapy with CHOP. The following CHOP regimen will be provided on Days 3 to 7 of each cycle with 6 cycles in maximum. E7777 dose will be escalated from 12 μg/kg/day to 15 and then to 18 in a stepwise fashion.

  • Cyclophosphamide: 750 mg/m2, i.v. on Day 3
  • Doxorubicin: 50 mg/m2, i.v. on Day 3
  • Vincristine: 1.4 mg/m2 (maximum dose 2.0 mg), i.v. on Day 3
  • Prednisolone: 100 mg/body, p.o. once daily for 5 days from Days 3 through 7

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401530

Contacts
Contact: Customer Joy Department, EJ _ML_CLNCL@hhc.eisai.co.jp

Locations
Japan
Recruiting
Nagoya, Aichi, Japan
Recruiting
Isehara, Kanagawa, Japan
Recruiting
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Tadashi Nakanishi Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01401530     History of Changes
Other Study ID Numbers: E7777-J081-101
Study First Received: July 18, 2011
Last Updated: November 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Neoplasms
Neoplasms by Histologic Type
Lymphoma
Non-Hodgkin
T- Cell
 Lymphatic Diseases
Lymphoproliferative Disorders
lmmune System Diseases
lmmunoproliferative Disorders

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
 Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013