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

Summary

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. In this prospective study, 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 are evaluated.

Conditions

• Myelodysplastic Syndrome
• Allogeneic Hematopoietic Stem Cell Transplantation
• Conditioning

Interventions

DRUG

Granulocyte 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.

DRUG

Decitabine (DAC)

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

DRUG

Busulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .

DRUG

Cyclophosphamide (CY)

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

DRUG

Fludarabine (FLU)

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

Sponsors & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• First People's Hospital of Chenzhou

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2023-07-31

Completion

2024-07-31

Countries

• China

Study Locations