G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing Allo-HSCT
NCT ID: NCT05449899
Last Updated: 2022-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
232 participants
INTERVENTIONAL
2022-07-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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G-CSF+DAC+BF
For patients with sAML undergoing allo-HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BF conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -6 to -3, Fludarabine (FLU) 30mg/m2/ day on days -7 to -3.
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.
Decitabine (DAC)
Decitabine was administered at 20mg/m2/day on days -14 to -10.
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 .
Fludarabine (FLU)
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
G-CSF+DAC+BUCY
For patients with sAML undergoing allo-HSCT, Granulocyte Colony -Stimulating Factor (G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -7 to -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3, -2.
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.
Decitabine (DAC)
Decitabine was administered at 20mg/m2/day on days -14 to -10.
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 .
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.
Interventions
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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.
Decitabine (DAC)
Decitabine was administered at 20mg/m2/day on days -14 to -10.
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 .
Fludarabine (FLU)
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous allo-HSCT
* Uncontrolled infections
* Liver or renal dysfunction
* Severe concomitant conditions not suitable for the trial
18 Years
65 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Guangzhou First People's Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
First People's Hospital of Chenzhou
OTHER
The Seventh Affiliated Hospital of Sun Yat-sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Xuanli
Professor
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DAC-BUCY vs DAC-BF-sAML-2022
Identifier Type: -
Identifier Source: org_study_id
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