PD-1 Inhibitor Combined with Azacitidine and HAG Regimen for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia:A Prospective,Single-Arm,Phase Ⅱ Clinical Study
10.19746/j.cnki.issn1009-2137.2025.04.007
- VernacularTitle:PD-1抑制剂联合阿扎胞苷和HAG方案治疗复发难治性急性髓系白血病:一项前瞻性、单臂、Ⅱ期临床研究
- Author:
Cheng-Sen CAI
1
;
Ru-Ju WANG
1
;
Xiao-Yan XU
1
;
Cheng-Yuan GU
1
;
Hui-Zhu KANG
1
;
Yue-Jun LIU
1
;
Yue HAN
1
Author Information
1. 苏州大学附属第一医院,江苏省血液研究所,国家卫生健康委员会血栓及止血重点研究室,国家血液系统疾病临床医学研究中心,江苏苏州 215006
- Publication Type:Journal Article
- Keywords:
PD-1 inhibitor;
relapsed/refractory acute myeloid leukemia;
HAG;
azacitidine
- From:
Journal of Experimental Hematology
2025;33(4):972-979
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of PD-1 inhibitor combined with azacitidine and HAG regimen in the treatment of relapsed/refractory acute myeloid leukemia(R/R AML).Methods:This study is a prospective,single-arm,phase Ⅱ clinical trial that included R/R AML patients who met the inclusion criteria and were treated at The First Affiliated Hospital of Soochow University from December 2020 to August 2023.Patients could undergo allogeneic hematopoietic stem cell transplantation(allo-HSCT)after salvage therapy.The efficacy and safety were evaluated.Results:Twenty patients were enrolled,including 14 males and 6 females,with an average age of(50.7±15.3)years.The overall response rate(ORR)after one cycle of the treatment was 75.0％(15/20),and 35.0％(7/20)of the patients achieved complete remission(CR)or complete remission with incomplete hematologic recovery(CRi)after two cycles of the treatment.Eight patients received allo-HSCT.The main adverse events were hematologic toxicities,and no grade 5 adverse events occurred.Conclusion:The combination of PD-1 inhibitor,azacitidine,and the HAG regimen is a feasible and relatively safe treatment option for R/R AML,thus,to be worth further study.
