Acute Myeloid Leukemia
Conditions
Keywords
AML CR, allogeneic hematopoietic cell transplantation, busulfan, fludarabine, ATG
Brief summary
The purpose of this study is to evaluate the effect of various clinical variables including HLA-disparity and NK cell-related variables, upon outcomes of allogeneic hematopoietic cell transplantation (HCT) using uniform conditioning regimen including busulfan, fludarabine, and antithymocyte globulin (ATG) in patients with acute myeloid leukemia (AML) in the first complete remission (CR). The donors for allogeneic HCT include HLA-matched siblings, matched unrelated donors, and haploidentical family donors. Therefore, the endpoints of the study are engraftment, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, leukemia recurrence, non-relapse mortality, and relapse-free (RFS) and overall survival (OS) of patients.
Interventions
perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with non-promyelocytic AML (intermediate-risk or high-risk diseases by NCCN guideline 2016) in the first CR * Patients should be 16 years of age or more and 75 years of age or less * The performance status of the patients should be 70 or over by Karnofsky performance scale * Patients should have adequate hepatic function (bilirubin less than 2.0 mg/dl, AST less than three times the upper normal limit) * Patients should have adequate renal function (creatinine less than 2.0 mg/dl) * Patients should have adequate cardiac function (ejection fraction \> 40% on MUGA scan) * Patients and stem cell donors must sign informed consent * For hematopoietic cell donor, if a patient has an HLA-matched sibling (65 years or younger), that sibling will be a cell donor. If a patient does not have an HLA-matched sibling but an HLA-A, B, C, DRB1 7-8/8 matched unrelated donor, the unrelated donor will be a cell donor. If a patient has neither HLA-matched sibling nor unrelated donor, an HLA-haploidentical familial donor will be a cell donor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| leukemia recurrence | from HCT (day of donor cell infusion) to leukemia recurrence at 2 years after HCT | reappearance of blast \>5% in bone marrow; reappearance of leukemia blast in extramedullary sites |
| engraftment | from HCT to neutrophil count over >500/uL at 30 days after HCT | recovery of absolute neutrophil count over \>500/uL |
| GVHD, acute and chronic | from HCT to the occurrence of GVHD at 2 years after HCT | occurrence of acute or chronic GVHD after HCT |
| Non-relapse mortality | from HCT to the occurrence of death without leukemia recurrence at 2 years after HCT | occurrence of death without leukemia recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relapse free survival | from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT | survival without leukemia recurrence/death |
| overall survival | from HCT to the last follow-up or death at 2 years after HCT | survival regardless of leukemia recurrence |
Countries
South Korea