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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00050999 |
Purpose
The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Sezary Syndrome |
Drug: ONTAK |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25 |
| Estimated Enrollment: | 195 |
| Study Start Date: | June 1995 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
Contacts and Locations
Hide Study Locations| United States, Texas | |
| University of Texas, M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Australia, New South Wales | |
| Westmead Hospital, Department of Haematology | |
| Westmead, New South Wales, Australia, 2145 | |
| Level 4 Department of Haematology Royal North Shore Hospital | |
| St. Leonard's, New South Wales, Australia, 2065 | |
| Australia, Queensland | |
| Mater Misericordiae Adult Hospital | |
| South Brisbane, Queensland, Australia, 4101 | |
| Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| LKH Universitatsklinikum Graz | |
| Graz, Austria, A-8036 | |
| Canada, Alberta | |
| Cross Cancer Centre | |
| Edmonton, Alberta, Canada | |
| Canada, Ontario | |
| Hamilton Regional Cancer Center | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada | |
| Germany | |
| Universitatsklinikum Charite | |
| Berlin, Germany | |
| J.W. Goethe University Frankfurt | |
| Frankfurt, Germany, 60590 | |
| University of Erlangen | |
| Erlangen, Germany, 91052 | |
| Universitatsklinikum Mannheim | |
| Mannheim, Germany, 68135 | |
| Universitatsklinikum Munster | |
| Munster, Germany, D-48149 | |
| Universitatsklinikum Essen | |
| Essen, Germany, 45122 | |
| Universitatskrankenhaus Eppendorf | |
| Hamburg, Germany, 20246 | |
| Sektion Dermatologische Onkologie | |
| Tubingen, Germany, D-72076 | |
| Netherlands | |
| LUMC, Department of Dermatology | |
| Leiden, Netherlands, 2333 ZA | |
| Poland | |
| Regional Oncological Center, Dept. of Chemotherapy | |
| Lodz, Poland, 93-509 | |
| Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie | |
| Warsaw, Poland, 02-781 | |
| Medical Academy in Gdansk, Dept. of Hematology | |
| Gdansk, Poland, 80-952 | |
| Klinika Hematoonkologii Akademii Medycznej w Lublinie | |
| Lublin, Poland, 20-950 | |
| The Medical University of Warsaw, Central Clinical Hospital | |
| Warsaw, Poland, 02-097 | |
| Oddzial Chorob Wewnetrznych i Hematologii | |
| Poznan, Poland, 61-833 | |
| Russian Federation | |
| St. Petersburg Pavlov State Medical University | |
| St. Petersburg, Russian Federation | |
| Burdenko Main Military Clinical Hospital | |
| Moscow, Russian Federation | |
| Central Research Institute of Skin and Venereal Diseases | |
| Moscow, Russian Federation | |
| Blokhin Russian Cancer Research Center, RAMS | |
| Moscow, Russian Federation | |
| Haematology Research Center RAMS | |
| Moscow, Russian Federation | |
| Samara Regional Clinical Hospital | |
| Samara, Russian Federation, 443095 | |
| Switzerland | |
| Universitatsspital Zurich Dermatologische Klinik | |
| Zurich, Switzerland | |
| United Kingdom | |
| St. John's Institute of Dermatology | |
| London, United Kingdom | |
| City Hospital | |
| Nottingham, United Kingdom | |
| Southampton General Hospital | |
| Southampton, United Kingdom | |
| Study Director: | Elyane Lombardy, M.D. | Ligand Pharmaceuticals |
More Information
| Study ID Numbers: | 93-04-11 |
| Study First Received: | December 31, 2002 |
| Last Updated: | February 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00050999 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Sezary Syndrome Mycosis Fungoides Pharmacologic Actions Lymphatic Diseases Neoplasms |
Pathologic Processes Therapeutic Uses Denileukin diftitox Syndrome Lymphoma, T-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |