Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
NCT ID: NCT00051012
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
86 participants
INTERVENTIONAL
1995-09-30
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ONTAK
Eligibility Criteria
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Inclusion Criteria
* 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
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
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
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
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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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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93-04-14
Identifier Type: -
Identifier Source: org_study_id
NCT00005620
Identifier Type: -
Identifier Source: nct_alias
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