Status:
COMPLETED
Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
15-70 years
Phase:
PHASE3
Brief Summary
1. At the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan...
Detailed Description
1. TREATMENT PLAN * The patients will be admitted to laminar air flow room. * The patients will have triple lumen Hickman central venous catheter (CVC) placed. Vancomycin 1 gm IV immediately pr...
Eligibility Criteria
Inclusion
- Patients with acute leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, and other hematologic malignancies.
- Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor.
- Patients should be 15 years of age or older, but younger than 70 years.
Exclusion
- Patients have major illness or organ failure.
- Patients have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00774280
Start Date
May 1 2002
End Date
December 1 2010
Last Update
February 14 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736