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G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing Allo-HSCT

NCT05449899 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2022-07-08

No results posted yet for this study

Summary

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

Conditions

  • Secondary Acute Myeloid Leukemia Evolving From MDS
  • 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

Fludarabine (FLU)

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

DRUG

Cyclophosphamide (CY)

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

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

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

    collaborator OTHER

  • First People's Hospital of Chenzhou

    collaborator OTHER

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449899 on ClinicalTrials.gov