Allogeneic Hematopoietic Stem Cell Transplantation, Conditions, Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
Conditions
Brief summary
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Detailed description
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Interventions
DRUGDecitabine
Decitabine was administered at 20mg/m2/day on days -14 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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, 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
* MLL+ acute leukemia undergoing allo-HSCT * 14-65 years
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 |
|---|---|
| relapse rate | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| transplant-related mortality (TRM) | 2 year |
| overall survival (OS) | 2 year |
| disease-free survival (DFS) | 2 year |
Countries
China
Contacts
Primary ContactQifa Liu
Backup ContactQifa Liu
Outcome results
None listed