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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2005-005966-35 | |||
| Sorafenib in AML |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Chemotherapy + Placebo |
|
| B | Active Comparator | Chemotherapy + Sorafenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | 2 x 400 mg/d |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Event Free Survival of all AML patients |
| Measure | Description | Time Frame |
|---|---|---|
| Median Event Free Survival of AML patients with Flt3-ITD mutations | ||
| Median Event Free Survival of the patients in each of the four strata (Flt3 Non-ITD/NPM1 WT, Flt3 Non-ITD/NPM1 mut, Flt3 ITD/NPM1 WT, Flt3 ITD/NPM1 mut) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert Serve, MD | Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Campus Benjamin Franklin, Med. Klinik III | Berlin | 12203 | Germany | |||
| Klinikum Chemnitz GmbH, Klinik für Innere Medizin III |
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| Placebo |
| Drug |
Chemotherapy + Placebo |
|
| Median Overall Survival of AML patients with Flt3-ITD mutations |
| Median Overall Survival of all AML patients |
| Rate of Complete Remission in all AML patients |
| Rate of Molecular Remission in all AML patients |
| Toxicity |
| Evidence of Minimal Residual Disease in all AML patients |
| Development of Biomarkers indicating the course of disease |
| Chemnitz |
| 09113 |
| Germany |
| Klinikum der Universität zu Köln, Klinik I für Innere Medizin | Cologne | 50937 | Germany |
| Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik I | Dresden | 01307 | Germany |
| St. Johannes Hospital, Medizinische Klinik II | Duisburg | 47166 | Germany |
| Universitätsklinikum Essen, Zentrum für Innere Medizin, Medizinische Klinik und Poliklinik für Hämatologie | Essen | 45147 | Germany |
| Klinikum der J. W. Goethe-Universität Frankfurt am Main, Medizinische Klinik II | Frankfurt am Main | 60590 | Germany |
| Allgemeines Krankenhaus St. Georg, Hämatologische Abteilung | Hamburg | 20099 | Germany |
| Universitätsklinikum Heidelberg, Med. Klinik V | Heidelberg | D-69120 | Germany |
| Klinikum der Johannes Gutenberg Universität, 3. Medizinische Klinik und Poliklinik | Mainz | 55101 | Germany |
| Philipps Universität, Abteilung für Hämatologie, Onkologie und Immunologie | Marburg | 35043 | Germany |
| Klinik für Hämatologie und Onkologie Klinikum Minden | Minden | 32423 | Germany |
| TU München, Medizinische Klinik III | München | 81675 | Germany |
| Universitätsklinikum Münster, Medizinische Klinik A | Münster | 48149 | Germany |
| Klinikum Nürnberg, 5. Medizinische Klinik Einheit für Knochenmarktransplantation | Nuremberg | 90419 | Germany |
| Universität Regensburg, Abteilung für Hämatologie und Internistische Onkologie | Regensburg | 93042 | Germany |
| Robert-Bosch Krankenhaus Stuttgart | Stuttgart | 70376 | Germany |
| Julius-Maximilians-Universität Würzburg, Medizinische Klinik und Poliklinik II | Würzburg | 97979 | Germany |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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