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Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients

Phase 4
Completed
Conditions
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Registration Number
NCT00051012
Lead Sponsor
Eisai Inc.
Brief Summary

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
86
Inclusion Criteria
  • Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
  • CTCL disease Stage Ia - III.
  • History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
  • Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
  • No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
  • No systemic infections.
  • ECOG performance status of 0 or 1.
Exclusion Criteria

• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary Outcome Measures
NameTimeMethod
Time-to-Treatment Failure
Time-to-Progression
Duration of Response

Trial Locations

Locations (34)

University of Texas, M.D. Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Level 4 Department of Haematology Royal North Shore Hospital

🇦🇺

St. Leonard's, New South Wales, Australia

Westmead Hospital, Department of Haematology

🇦🇺

Westmead, New South Wales, Australia

Mater Misericordiae Adult Hospital

🇦🇺

South Brisbane, Queensland, Australia

Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital

🇦🇺

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Institute

🇦🇺

Melbourne, Victoria, Australia

LKH Universitatsklinikum Graz

🇦🇹

Graz, Austria

Allgemeines Krankenhaus der Stadt Wien

🇦🇹

Vienna, Austria

Cross Cancer Centre

🇨🇦

Edmonton, Alberta, Canada

Hamilton Regional Cancer Center

🇨🇦

Hamilton, Ontario, Canada

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University of Texas, M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States

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