Venetoclax Combined with CACAG Regimen in the Treatment of Patients with Refractory/Relapse Acute Myeloid Leukemia:A Prospective Clinical Study
10.19746/j.cnki.issn1009-2137.2024.01.015
- VernacularTitle:维奈克拉联合CACAG方案治疗难治/复发急性髓系白血病的前瞻性临床研究
- Author:
Wen-Jing GAO
1
,
2
;
Jing-Jing YANG
;
Meng LI
;
Ya-Nan WEN
;
Yi-Fan JIAO
;
Ning LE
;
Yu-Chen LIU
;
Nan WANG
;
Sai HUANG
;
Li-Ping DOU
Author Information
1. 解放军医学院
2. 中国人民解放军总医院第五医学中心血液病医学部,北京 100853
- Keywords:
venetoclax combined with CACAG regimen;
acute myeloid leukemia;
refractory;
relapse;
prospective clinical study
- From:
Journal of Experimental Hematology
2024;32(1):90-95
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the efficacy and safety of Venetoclax combined with CACAG regimen in treatment of patients with refractory/relapse acute myeloid leukemia(R/R AML).Methods:The study was a singlecenter prospective clinical trial.The enrolled patients met the criteria for R/R AML.Treatment included Azacidine(75mg/m2,d1-7),Ara-C(75-100 mg/m2,q12h,d1-5),Aclacinomycin(20 mg d1,d3,d5),Chidamide(30 mg d1,d4),Venetoclax(100 mg d1,200 mg d2,400 mg d3-d14,in combination with Triazole Drug,reduced to 100 mg/d),and granulocyte colony-stimulating factor(300 μg/d until neutrophil recovery).The primary endpoint of observation was overall response rate after 1 course of treatment.Results:A total of 19 patients were enrolled from January 2022 to April 2023.After 1 course of treatmen,the overall response rate was 81.3％(13/16),the CR rate was 68.8％(11/16),and the PR was 12.5％(2/16).Among the 11 patients who got CR/CRi,8 cases achieved CRm(minimal residual disease negative CR)and 3 cases did not.As of March 27,2023,the median follow-up time was 111(19-406)days.The six-month overall survival and progression-free survival rates were both 55.7％,the 1-year overall survival and progression-free survival rates were 46.4％and 47.7％,respectively.In addition,compared with the non-CRm group,CRm patients had a better PFS(377 days vsi11 days,P=0.046).Treatment-related adverse events were mainly 3-4 degrees of bone marrow suppression,complicated by various degrees of infection(n=12),hypokalemia(n=12)and hypocalcemia(n=10)and elevated liver enzymes(n=8),of which 3/4 degrees accounted for 47.4％(9/19).Conclusion:The Venetoclax combined with CACAG regimen is an effective salvage therapy for patients with R/R AML,with high remission rate and safety profile.
