Overview

Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cooperative Study Group A for Hematology
Treatments:
Busulfan
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Vidarabine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.