Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
NCT ID: NCT00050999
Last Updated: 2008-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
195 participants
INTERVENTIONAL
1995-06-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ONTAK
Eligibility Criteria
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Inclusion Criteria
* Patient must have had 1 to 3 prior CTCL 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 regimen is permitted. Topical or systemic steroids are not considered a therapy;
* Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
* Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
* Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
* No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
* No systemic infections;
* Willingness to be randomized to a placebo treatment only arm;
* ECOG performance status 0 or 1;
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Principal Investigators
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Elyane Lombardy, M.D.
Role: STUDY_DIRECTOR
Ligand Pharmaceuticals
Locations
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University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States
Level 4 Department of Haematology Royal North Shore Hospital
Saint 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
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
Jewish General Hospital
Montreal, Quebec, Canada
Universitatsklinikum Charite
Berlin, , Germany
University of Erlangen
Erlangen, , Germany
Universitatsklinikum Essen
Essen, , Germany
J.W. Goethe University Frankfurt
Frankfurt, , Germany
Universitatskrankenhaus Eppendorf
Hamburg, , Germany
Universitatsklinikum Mannheim
Mannheim, , Germany
Universitatsklinikum Munster
Münster, , Germany
Sektion Dermatologische Onkologie
Tübingen, , Germany
LUMC, Department of Dermatology
Leiden, , Netherlands
Medical Academy in Gdansk, Dept. of Hematology
Gdansk, , Poland
Regional Oncological Center, Dept. of Chemotherapy
Lodz, , Poland
Klinika Hematoonkologii Akademii Medycznej w Lublinie
Lublin, , Poland
Oddzial Chorob Wewnetrznych i Hematologii
Poznan, , Poland
The Medical University of Warsaw, Central Clinical Hospital
Warsaw, , Poland
Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
Warsaw, , Poland
Blokhin Russian Cancer Research Center, RAMS
Moscow, , Russia
Burdenko Main Military Clinical Hospital
Moscow, , Russia
Central Research Institute of Skin and Venereal Diseases
Moscow, , Russia
Haematology Research Center RAMS
Moscow, , Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
Samara Regional Clinical Hospital
Samara, , Russia
Universitatsspital Zurich Dermatologische Klinik
Zurich, , Switzerland
St. John's Institute of Dermatology
London, , United Kingdom
City Hospital
Nottingham, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.
Other Identifiers
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93-04-11
Identifier Type: -
Identifier Source: org_study_id
NCT00002683
Identifier Type: -
Identifier Source: nct_alias
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