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Sponsors and Collaborators: |
Hannover Medical School University of Ulm Klinikum der J.W. Goethe Universitaet University Hospital Freiburg Zentralklinikum, Augsburg Humboldt-Universität zu Berlin Universitätsklinik Eppendorf University Hospital, Ghent Medizinische Universitätsklinik Tübingen Klinikum Hanover-Siloah Hospital Ev. Krankenhaus Essen-Werden Klinikum Wuppertal GmbH |
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Information provided by: | Hannover Medical School |
ClinicalTrials.gov Identifier: | NCT00209833 |
This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.
Condition | Intervention | Phase |
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De Novo Akute Myeloid Leukemia (AML) Secondary Acute Myeloid Leukemia (AML) Refractory Anemia With Excess of Blasts in Transformation |
Drug: Cytarabine Drug: Idarubicin Drug: Etoposide Drug: Fludarabine Drug: G-CSF Drug: Daunorubicine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial) |
Estimated Enrollment: | 200 |
Study Start Date: | January 1999 |
Estimated Study Completion Date: | September 2005 |
Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype.
Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT)
Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR
Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Hannover Medical School | |
Hannover, Germany, 30625 |
Principal Investigator: | Arnold Ganser, Prof. Dr. | Hannover Medical School |
Study ID Numbers: | AML 01/99 trial |
Study First Received: | September 13, 2005 |
Last Updated: | November 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00209833 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Myelodysplastic syndromes Refractory anemia Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Anemia Acute myelogenous leukemia Fludarabine monophosphate Leukemia, Myeloid Leukemia, Myeloid, Acute Etoposide phosphate |
Leukemia Idarubicin Preleukemia Anemia, Refractory Neoplasm Metastasis Fludarabine Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Etoposide Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses |