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Sponsors and Collaborators: |
University Hospital Muenster Dresden University of Technology Philipps University Marburg Medical Center Center of Hematology/Oncology and Bone Marrow Transplantation, Idar-Oberstein Universitätsklinikum Hamburg-Eppendorf Hannover Medical School Ludwig-Maximilians - University of Munich University Hospital, Essen Johann Wolfgang Goethe University Hospitals Deutsche Klinik für Diagnostik, KMT Zentrum, Wiesbaden Charite University, Berlin, Germany |
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Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00125606 |
For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Procedure: conditioning for allogeneic HSCT |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase 3 Trial for Patients With AML in CR2 Comparing TBI 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide |
Estimated Enrollment: | 172 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, NRW | |
Department of Medicine/Hematology and Oncology | Recruiting |
Muenster, NRW, Germany, 48149 | |
Contact: Matthias Stelljes, M.D. +49 251 83-52801 stelljes@uni-muenster.de | |
Principal Investigator: Matthias Stelljes, M.D. |
Principal Investigator: | Matthias Stelljes, M.D. | Department of Medicine/Hematology and Oncology |
Responsible Party: | University of Muenster ( University of Muenster ) |
Study ID Numbers: | AML_CR2_allo_HSCT |
Study First Received: | July 26, 2005 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00125606 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
AML allogeneic HSCT reduced intensity conditioning randomized trail |
Leukemia Acute Myelocytic Leukemia Immunologic Factors Antineoplastic Agents, Alkylating Fludarabine Fludarabine monophosphate |
Cyclophosphamide Leukemia, Myeloid Antirheumatic Agents Leukemia, Myeloid, Acute Alkylating Agents Immunosuppressive Agents |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid Cyclophosphamide Leukemia, Myeloid, Acute Immunosuppressive Agents |
Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Alkylating Agents |