Status:
COMPLETED
Early Allogeneic Blood Stem Cell Transplantation in High-risk Acute Myeloid Leukemia (AML)
Lead Sponsor:
University Hospital Carl Gustav Carus
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
Karyotype is a major prognostic risk factor in patients with acute myeloid leukemia (AML) translating into unfavourable outcome in case of poor-risk cytogenetic aberrations. Several studies have shown...
Detailed Description
Only patients with newly-diagnosed AML are eligible for this prospective study. An immediate donor-search, either within the family or in volunteer donor registries, will be performed at diagnosis irr...
Eligibility Criteria
Inclusion
- newly-diagnosed AML
- either poor risk cytogenetics and/or bad response to the first cycle of IC defined by more than 10% marrow blasts on day 15
- HLA-compatible donor (maximum one HLA-antigen mismatch)
Exclusion
- no donor
- Age \< 16 years \> 75 years
- Cardiac insufficiency requiring treatment or symptomatic coronary artery disease
- Hepatic disease, with AST \> 2 times normal
- Severe hypoxemia , pO2 \< 70 mm Hg, with decreased DLCO \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted
- Impaired renal function (creatinine \> 2 times normal or creatinine clearance \< 50% for age, weight, height)
- HIV-positive patients due to risk of reactivation or acceleration of HIV replication
- Female patients who are pregnant or breast feeding due to risks to fetus from conditioning regimen and potential risks to nursing infants
- Life expectancy severely limited by diseases other than malignancy
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00188136
Start Date
August 1 2002
End Date
December 1 2010
Last Update
December 8 2015
Active Locations (1)
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1
University hospital Carl Gustav Carus
Dresden, Germany, 01307