Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
- Conditions
- Acute Myeloid LeukemiaAllogeneic Hematopoietic Stem Cell TransplantationConditioning
- Interventions
- Drug: Modified BUCY
- Registration Number
- NCT03256071
- 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 myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- 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. However, relapse occured in as high as 30-50% high risk AML patients after allo-HSCT. Thus, the best conditioning regimen for this subgroup remains to be optimized. Low dose decitabine in combination with chemotherapy have been shown to improve comple remission rate of high risk AML patients. To reduce the relapse rate after allo-HSCT, low dose decitabine is added in the modified BUCY regimen. In this study, the safety and efficacy of low dose decitabine + modified BUCY vs modified BUCY myeloablative conditioning regimens in high risk undergoing allo-HSCT are evaluated.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decitabine plus Modified BUCY Decitabine plus Modified BUCY For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide. Modified BUCY Modified BUCY For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.
- Primary Outcome Measures
Name Time Method disease-free survival (DFS) 3 year time from randomization to the first of reccurrence or death
overall survival (OS) 3 year time from randomization to death from any cause
- Secondary Outcome Measures
Name Time Method veno-occlusive disease (VOD) 3 year incidence of veno-occlusive disease (VOD) events
graft-versus-host disease (GvHD) 3 year incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD)
transplant related mortality （TRM） 3 year cumulative incidence of transplant related mortality
relapse 3 year cumulative incidence of relapse
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China