Autologous Hematopoietic Stem Cell Transplantation, Acute Myeloid Leukemia, Conditioning
Conditions
Brief summary
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.
Detailed description
Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.
Interventions
DRUGIdarubicin（IDA）
Idarubicin was administered at 15mg/m2/day on days -12 and -10.
DRUGBusulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Zhujiang Hospital
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Intermediate-risk AML * Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens * With negative MRD before mobilization and collect of peripheral blood stem cells * Without HLA-matched donors (related and unrelated) * Refusal of haploidentical hematopoietic stem cell transplantation
Exclusion criteria
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| leukemia relapse rate | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS) | 2 year |
| disease-free survival (DFS) | 2 year |
| transplant-related mortality (TRM) | 2 year |
Countries
China
Outcome results
None listed