G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT

Granulocyte Colony-stimulating Factor+Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02744742

Enrollment

202

Registered

2016-04-20

Start date

2016-04-18

Completion date

2021-09-30

Last updated

2022-02-14

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

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study, the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are evaluated.

Detailed description

Allo-HSCT appears to be an efficient tool to cure patients with 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. BUCY conditioning regimen is the standard myeloablative regimen for MDS and AML secondary to MDS undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of G-CSF + Decitabine + BUCY and BUCY myeloablative conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.

Interventions

DRUGDecitabine

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

DRUGBusulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

DRUGCyclophosphamide (CY)

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

DRUGGranulocyte Colony-Stimulating Factor(G-CSF)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

Inclusion criteria

* RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT * 14-65 years

Exclusion criteria

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)

Design outcomes

Primary

Measure	Time frame
relapse rate	2 year

Secondary

Measure	Time frame
overall survival (OS)	2 year
disease-free survival (DFS)	2 year
transplant-related mortality (TRM)	2 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026