Status:
TERMINATED
Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission
Lead Sponsor:
University Hospital Carl Gustav Carus
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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-bod...
Detailed Description
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 ce...
Eligibility Criteria
Inclusion
- Diagnosis of acute myeloid leukemia in first remission
- Standard-or high-risk marrow cytogenetics
- HLA-matched related or unrelated donor available (in case of high-risk disease)
- Age 18 to 60
- Informed consent
- Consent of donor to donate peripheral blood stem cells
- sufficient liver function (elevation of transferases \< 2.5 x upper limit)
Exclusion
- AML with t(5;17)
- AML with t((8;21)
- clinically relevant heart failure (NYHA II-IV)
- Renal failure (creatinine \> 200 µg/ml)
- Liver function failure (bilirubin \> 3 mg/dl)
- Concomitant Neurological or psychiatric disease
- Contraindications to receive prescribed study medication
- HIV infection
- Pregnancy
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00150878
Start Date
December 1 2003
End Date
December 1 2010
Last Update
June 20 2013
Active Locations (1)
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1
Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307