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Sponsors and Collaborators: |
University Hospital Muenster Celgene Corporation Amgen |
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Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00915252 |
The primary purpose of the study is to determine, whether the addition of 5-azacytidine to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: azacitidine Drug: standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multi-Center Phase II Trail to Assess the Efficacy of 5-Azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML |
Estimated Enrollment: | 216 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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5-azacytidine: Experimental
Patients enrolled in this arm will receive standard induction and consolidation chemotherapy preceded by 5-azacytidine. These patients will additionally receive maintenance therapy with 5-azacytidine for one year after start of induction therapy.
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Drug: azacitidine
Starting dose to be determined during run-in dose finding part of the study. Starting dose of the interventional drug will be most likely either 75 or 37,5mg/m²/d resp. 18mg/m²/d. Application form: During induction therapy phase: i.v. on days -5--1 before standard chemotherapy for 1 or 2 cycles, During consolidation therapy: s.c. on days -5--1 before standard chemotherapy (2 cycles). During maintenance therapy: s.c. on days 1-5 on a 28day cycle till maximum one year after start of first induction therapy. |
standard chemotherapy: Active Comparator
Patients enrolled in this arm will receive standard chemotherapy treatment.
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Drug: standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine
Induction therapy: Daunorubicin 45mg/m²/d i.v.on days 3,4,5 AraC 100mg/m²/d i.v. on days 1-7 Consolidation therapy: AraC 1g/m² twice a day on day 1,3,5 |
Ages Eligible for Study: | 61 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carsten Müller-Tidow, MD | +49 (0)251 83-52995 | muellerc@uni-muenster.de |
Germany | |
Universitätsklinikum Münster, Medizinische Klinik und Poliklinik A | |
48149 Münster, Germany | |
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I | |
01307 Dresden, Germany | |
Klinikum der Johann Wolfgang Goethe-Universität Frakfurt am Main | |
60590 Frankfurt, Germany | |
Universitätsklinikum Erlangen, Medizinische Klinik 5 | |
91054 Erlangen, Germany | |
St. Bernward Krankenhaus Hildesheim, Medizinische Klinik II | |
31134 Hildesheim, Germany | |
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II | |
97070 Würzburg, Germany | |
Universitätsklinikum Essen, Klinik für Hämatologie | |
45122 Essen, Germany | |
Johannes Gutenberg-Universität Mainz Klinikum, III. Medizinische Klinik und Poliklinik | |
55101 Mainz, Germany | |
Klinikum Osnabrück, Klinik für Onkologie, Hämatologie, Immunologie | |
49076 Osnabrück, Germany | |
Asklepios Klinik St. Georg, Hämatologische Abteilung | |
20099 Hamburg, Germany | |
Klinikum rechts der Isar, III. Medizinische Klinik | |
81675 München, Germany | |
Klinikum der Universität Regensburg, Klinik und Poliklinik für Innere Medizin I | |
93042 Regensburg, Germany | |
Robert-Bosch-Krankenhaus, Zentrum für Innere Medizin | |
70376 Stuttgart, Germany | |
Phillips Universität Marburg, Fachbereich 20, ZIM | |
35032 Marburg, Germany | |
Klinikum Nürnberg, Medizinische Klinik 5 | |
90340 Nürnberg, Germany | |
Klinikum Chemnitz, Krankenhaus Küchenwald, Klinik für Innere Medizin III | |
09113 Chemnitz, Germany | |
Charite Campus Benjamin Franklin, Universitätsmedizin Berlin, Medizinische Klinik III | |
12203 Berlin, Germany |
Principal Investigator: | Carsten Müller-Tidow, MD | Universitätsklinikum Münster, Medizinische Klinik A |
Responsible Party: | University Hospital Muenster, Medizinische Klinik und Poliklinik A ( Prof. Dr. med. Carsten Müller-Tidow ) |
Study ID Numbers: | 101010 |
Study First Received: | June 3, 2009 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00915252 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Acute Myeloid Leukemia azacitidine elderly |
demethylating agent flt3 AML |
Antimetabolites Anti-Bacterial Agents Daunorubicin Leukemia Acute Myelocytic Leukemia |
Azacitidine Leukemia, Myeloid Leukemia, Myeloid, Acute Cytarabine |
Antimetabolites Daunorubicin Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Leukemia, Myeloid |
Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Azacitidine |