Status:
UNKNOWN
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jiangsu University
Conditions:
Acute Myeloid Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
12-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY as a myeloabl...
Detailed Description
Allo-HSCT is the most effective treatment stratagey for high risk acute myeloid leukemia. At present, modified BUCY is the standard conditioning regimen for AML undergoing allo-HSCT in our institute. ...
Eligibility Criteria
Inclusion
- Age 12 to 60 years.
- Diagnosis of high-risk acute myeloid leukemia at the time of transplant. ("High-risk" AML features are defined by the following: relapsed or primary refractory AML; Secondary AML（AML Secondary to myelodysplastic syndrome(MDS) or treatment-related AML); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5, monosomy 7, or deletion of 5q; or presence of FLT3 positive internal tandem duplication (FLT3/ITD+), particularly high allelic ratio.)
- Patient must have adequate pre-transplant organ function.
Exclusion
- Age \<12 or \>60 years.
- Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen.
- Any other severe concurrent diseases, or have a history of serious organ dysfunction.
- Pregnant or lactating females.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03256071
Start Date
September 1 2017
End Date
September 1 2021
Last Update
August 21 2017
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000