Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
- Conditions
- Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary 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
- 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.
• 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
Name Time Method Objective Rate of Response (ORR), defined as CR + CCR + PR
- Secondary Outcome Measures
Name Time Method 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
Scroll for more (24 remaining)University of Texas, M.D. Anderson Cancer Center🇺🇸Houston, Texas, United States