Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
Phase 3
18 Years
60 Years
18 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia
Both
Acute Myeloid Leukemia
Trial Information
Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
Inclusion Criteria:
- Patients with AML in second complete remission
- HLA-identical related (HLA * A, B, and DR) or HLA-compatible unrelated donor with
maximum of one Ag mismatch
- Ages 18-60 years
- Written informed consent from the patient
- Written informed consent from the donor
- No major organ dysfunction
Exclusion Criteria:
- Cardiac failure (New York Heart Association [NYHA] grade II-IV)
- Renal failure (creatinine > 2.0 mg/dl)
- Hepatic failure (total bilirubin > 3 mg/dl)
- Severe neurological/psychiatric disorder
- Previous allogeneic HSCT
- Contra-indications for used drugs
- HIV infection
- Non-compliance to processing of personal data according to the protocol
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
treatment related mortality
Principal Investigator
Matthias Stelljes, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Medicine/Hematology and Oncology
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AML_CR2_allo_HSCT
NCT ID:
NCT00125606
Start Date:
October 2004
Completion Date:
July 2011
Related Keywords:
- Acute Myeloid Leukemia
- AML
- allogeneic HSCT
- reduced intensity conditioning
- randomized trail
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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