Actively Recruiting
Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT
Led by Peking University People's Hospital · Updated on 2020-03-10
55
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with high-risk molecular biomarkers who still have detectable minimal residual disease(MRD) pre-HSCT were at very high risk of relapse, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastiv syndrome. It was reported that the combination of decitabine, with busufan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in patients with very high-risk AL and detectable MRD pre-HSCT.
CONDITIONS
Official Title
Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute leukemia patients with MLL-r, TLS-ERG, or SIL-TAL1 molecular markers
- Detectable minimal residual disease before allogeneic hematopoietic stem cell transplantation
- Age between 18 and 55 years
You will not qualify if you...
- Pregnant women
- Presence of uncontrolled severe infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Institute of Hematology,Beijing
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
X
Xiao-Jun Huang
CONTACT
C
Chen-Hua Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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