G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for High-risk MDS Undergoing Allo-HSCT

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    242
  • sponsor
    Nanfang Hospital of Southern Medical University
Updated on 4 October 2022
fludarabine
cyclophosphamide
busulfan
filgrastim
granulocyte colony stimulating factor
decitabine
transplant conditioning
colony stimulating factor
raeb i

Summary

Allo-HSCT is the most effective way to cure high-risk MDS patients. At present, the best conditioning regimen for high-risk MDS 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 high-risk MDS patients undergoing allo-HSCT are evaluated.

Description

Allo-HSCT is the most effective way to cure high-risk MDS patients. At present, the best conditioning regimen for high-risk MDS patients undergoing allo-HSCT remains in discussion. A previous study by the investigators 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 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, the investigators 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 high-risk MDS patients undergoing allo-HSCT.

Details
Condition Myelodysplastic Syndrome, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning
Treatment busulfan, Busulfan (BU), Cyclophosphamide (CY), Decitabine (DAC), Granulocyte Colony-Stimulating Factor(G-CSF), Fludarabine (FLU)
Clinical Study IdentifierNCT05453552
SponsorNanfang Hospital of Southern Medical University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Had a diagnosis of RAEB-1 or RAEB-2 with IPSS-R >3
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
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