Objective: To investigate the safety and efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) containing cladribine sequential busulfan regimen for refractory/relapsed acute myeloid leukemia (AML) . Methods: The clinical data of 12 refractory/relapsed AML patients received allo-HSCT with cladribine sequential busulfan regimen. Results: ① Of the 12 patients, 9 were males and 3 females, with a median age of 36 (27-50) years. The donors were identical sibling (3) , matched unrelated (1) and haploidentical family member (9) respectively. Nine patients reached partial remission and other remained no remission after chemotherapy before allo-HSCT. The median previous chemotherapy courses before allo-HSCT were 6 (2-13) . ② Conditioning regimen: Smostine 250 mg·m(-2)·d(-1), d-7; Cladribine 5 mg·m(-2)·d(-1), d-6 to d-2; Cytarabine Arabinoside 2 g·m(-2)·d(-1), d-6 to d-2; Busulfan 3.2 mg·m(-2)·d(-1), d-6 to d-3; Rabbit anti-human thymocyte immunoglobulin (ATG) 1.5 mg·m(-2)·d(-1) (unrelated donor transplantation) or 2.0-2.5 mg·m(-2)·d(-1) (haplo-HSCT) , d-4 to d-1. ③ Of the 12 patients, 11 patients attained complete haploidentical engraftment, one case occurred primary graft failure. The median durations for neutrophils and platelet implantations were 15 (15-21) and 19 (17-30) days respectively. ④After conditioning, no hepatic veno-occlusive diseases were observed, hemorrhagic cystitis occurred in 2 patients, 8 patients had fever, 3 cases experienced acute GVHD grade II, localized chronic GVHD occurred in 8 patients. ⑤The median follow-up was 8 (4-12) months. Leukemia relapse occurred in 2 patients at time of 6, 12 months after allo-HSCT. The estimated 1-year OS and DFS were (71.1±1.8) % and (62.2±1.8) %, respectively. Conclusions: allo-HSCT with cladribine sequential busulfan regimen was a feasible choice with favorable outcome for refractory/relapsed AML.
目的： 评估含克拉屈滨序预处理异基因造血干细胞移植（allo-HSCT）治疗难治/复发急性髓系白血病（AML）的疗效。 方法： 回顾性分析12例接受含克拉屈滨预处理allo-HSCT难治/复发AML患者的临床资料。 结果： ①12例患者中，男9例，女3例，中位年龄36（27~50）岁。亲缘全相合供者移植3例，无关供者移植1例，单倍型移植8例。移植前部分缓解9例，未缓解3例，移植前化疗中位疗程6（2~13）个。②预处理：司莫司汀250 mg·m(-2)·d(-1)，-7 d；克拉屈滨5 mg·m(-2)·d(-1)，-6 d~-2 d；阿糖胞苷2 g·m(-2)·d(-1)，-6 d~-2 d；白消安3.2 mg·m(-2)·d(-1)，-6 d~-3 d；兔抗人胸腺细胞免疫球蛋白（ATG）1.5 mg·m(-2)·d(-1)（无关供者移植）或2.0~2.5 mg·m(-2)·d(-1)（单倍型移植），-4 d~-1 d。③11例患者获得造血重建，1例发生原发植入失败。可评估患者中，中性粒细胞植入时间为15（15~21）d，中位血小板植入时间为19（17~30）d。④预处理过程中，12例患者均未发生肝静脉闭塞病，2例患者发生出血性膀胱炎。移植过程中8例出现发热，均经抗感染治疗后好转。3例患者发生Ⅱ度急性GVHD。至随访截止9例存活患者中8例发生慢性局限型GVHD。⑤中位随访时间为8（4~12）个月，2例患者分别在移植后6、12个月复发。预期1年总生存率为（71.1±1.8）%，无病生存率为（62.2±1.8）%。 结论： 含克拉屈滨预处理allo-HSCT可作为难治/复发AML患者的可选治疗方案。.
Keywords: Acute myeloid leukemia; Allogeneic hematopoietic stem cell transplantation; Cladribine.