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

G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With High-risk MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05453552

Enrollment

242

Registered

2022-07-12

Start date

2022-07-01

Completion date

2024-12-31

Last updated

2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning

Brief 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.

Detailed 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.

Interventions

DRUGGranulocyte Colony-Stimulating Factor(G-CSF)

G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.

DRUGDecitabine (DAC)

Decitabine was administered at 20mg/m2/day on days -14 to -10.

DRUGBusulfan

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group.

DRUGFludarabine (FLU)

Fludarabine was administered at 30 mg/m2/day on days -7 to -3.

DRUGCyclophosphamide (CY)

Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.

DRUGBusulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Non-relapse mortality (NRM)	1 year

Secondary

Measure	Time frame
Overall survival (OS)	1 year
Disease-free survival (DFS)	1 year
Cumulative incidence of relapse	1 year
Adverse effects	within 100 days post-transplantation

Countries

China

Contacts

Primary ContactLi Xuan

356135708@qq.com+86-020-62787883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026