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Sponsored by: |
University Hospital Carl Gustav Carus |
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Information provided by: | University Hospital Carl Gustav Carus |
ClinicalTrials.gov Identifier: | NCT00150878 |
The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mg/kg Cyclophosphamide.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Procedure: Conditioning therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission |
Estimated Enrollment: | 172 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | December 2008 |
Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.
In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.
Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.
After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.
The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.6 and a first-error of 5%, 164 patients will have to be randomized.
Secondary endpoints include:
3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martin Bornhäuser, MD | +49351458 ext 4704 | martin.bornhaeuser@uniklinikum-dresden.de |
Contact: Catrin Theuser | +49351 458 ext 2869 | catrin.theuser@uniklinikum-dresden.de |
Germany | |
Medizinische Klinik und Poliklinik I | Recruiting |
Dresden, Germany, 01307 | |
Contact: Martin Bornhäuser, MD +49351458 ext 4704 martin.bornhaeuser@uniklinikum-dresden.de |
Study Director: | Gerhard Ehninger, MD | Director of Med. Klink und Poliklinik I, Technical University Dresden |
Study ID Numbers: | 9005-2003 |
Study First Received: | September 6, 2005 |
Last Updated: | April 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00150878 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Reduced-intensity conditioning Fludarabine Acute myeloid Leukemia Treatment-related mortality |
Leukemia Acute myelogenous leukemia Fludarabine Fludarabine monophosphate |
Cyclophosphamide Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |