Allogeneic HCT From Donor-sources of Matched-sibling, Matched-unrelated, or Haploidentical-family Donors Using Uniform Conditioning Regimen of Busulfan, Fludarabine, and Antithymocyte Globulin for AML in Remission - an Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Non-relapse mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Non-relapse mortality
时间窗: from HCT to the occurrence of death without leukemia recurrence at 2 years after HCT
occurrence of death without leukemia recurrence
engraftment
时间窗: 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
时间窗: from HCT to the occurrence of GVHD at 2 years after HCT
occurrence of acute or chronic GVHD after HCT
leukemia recurrence
时间窗: 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
次要结局
- relapse free survival(from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT)
- overall survival(from HCT to the last follow-up or death at 2 years after HCT)
研究者
Kyoo-Hyung Lee
MD, Professor
Asan Medical Center