G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing Allo-HSCT

G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With Secondary Acute Myeloid Leukemia Evolving From MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Allo-HSCT is the most effective way to cure sAML patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT are evaluated.

Allo-HSCT is the most effective way to cure secondary acute myeloid leukemia evolving from MDS (sAML) patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+ BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT.

Inclusion Criteria:

• Had a diagnosis of sAML
• Age 18 to 65 years old
• ECOG performance status of 0-2
• HCT-CI of 0-2
• Were willing to undergo allo-HSCT

Exclusion Criteria:

• Therapy-related MDS
• Previous allo-HSCT
• Uncontrolled infections
• Liver or renal dysfunction
• Severe concomitant conditions not suitable for the trial