Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning, Elderly
Conditions
Brief summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Interventions
DRUGDecitabine
Decitabine was administered at 20mg/m2/day on days -9 to -7.
DRUGBusulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
DRUGFludarabine(Flu)
Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* AML patients older than 60 years, younger than 80 years * In complete remission before transplantation * With HLA-matched sibling donors
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 |
|---|---|
| overall survival (OS) | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival (DFS) | 2 year |
| relapse | 2 year |
| transplant-related mortality (TRM) | 2 year |
Countries
China
Contacts
Primary ContactLi Xuan
Outcome results
None listed