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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONTAK | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Rate of Response (ORR), defined as CR + CCR + PR |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Treatment Failure | ||
| Time-to-Progression | ||
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.
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| Name | Affiliation | Role |
|---|---|---|
| Elyane Lombardy, M.D. | Ligand Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas, M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Level 4 Department of Haematology Royal North Shore Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23770157 | Derived | 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. |
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| Saint Leonard's |
| New South Wales |
| 2065 |
| Australia |
| Westmead Hospital, Department of Haematology | Westmead | New South Wales | 2145 | Australia |
| Mater Misericordiae Adult Hospital | South Brisbane | Queensland | 4101 | Australia |
| Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Peter MacCallum Cancer Institute | Melbourne | Victoria | 3002 | Australia |
| LKH Universitatsklinikum Graz | Graz | A-8036 | Austria |
| Allgemeines Krankenhaus der Stadt Wien | Vienna | A-1090 | 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 | 91052 | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| J.W. Goethe University Frankfurt | Frankfurt | 60590 | Germany |
| Universitatskrankenhaus Eppendorf | Hamburg | 20246 | Germany |
| Universitatsklinikum Mannheim | Mannheim | 68135 | Germany |
| Universitatsklinikum Munster | Münster | D-48149 | Germany |
| Medical Academy in Gdansk, Dept. of Hematology | Gdansk | 80-952 | Poland |
| Regional Oncological Center, Dept. of Chemotherapy | Lodz | 93-509 | Poland |
| Klinika Hematoonkologii Akademii Medycznej w Lublinie | Lublin | 20-950 | Poland |
| Oddzial Chorob Wewnetrznych i Hematologii | Poznan | 61-833 | Poland |
| The Medical University of Warsaw, Central Clinical Hospital | Warsaw | 02-097 | Poland |
| Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie | Warsaw | 02-781 | 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 | 443095 | 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 |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C078456 | denileukin diftitox |
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