Status:
TERMINATED
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Technische Universität Dresden
Philipps University Marburg
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00125606
Start Date
October 1 2004
End Date
July 1 2011
Last Update
December 18 2012
Active Locations (1)
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1
Department of Medicine/Hematology and Oncology
Münster, North Rhine-Westphalia, Germany, 48149