Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Conditioning
  • Myelodysplastic Syndrome
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 14 years and 65 years
Gender
Both males and females

Description

Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve...

Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS 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 RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT.

Tracking Information

NCT #
NCT04713956
Collaborators
  • Peking University People's Hospital
  • Institute of Hematology and Blood Diseases Hospital
  • Guangzhou First People's Hospital
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • First People's Hospital of Chenzhou
  • First Affiliated Hospital of Guangxi Medical University
Investigators
Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University