Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen
Completed
Cooperative Study Group A for Hematology
Phase 3
2002-05-01
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 plus fludarabine; BuFlu).
2. Randomization will be a stratified permuted-block design. 2.1The patients will be
stratified into standard risk vs. high risk group, and related vs. unrelated donor.
Standard risk group will be defined as follows: patients with acute leukemia in first
remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will
be defined as follows: patients with acute leukemia in relapse or in second or
subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB
categories).
2.2.Pre-assigned block size is 8.
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