Influence of Molecular Abnormalities on Treatment Response of the Regimen of Venetoclax Plus Azacytidine Combined With Homoharringtonine Versus Venetoclax Plus Hypomethylating Agents (HMA) in Relapsed/Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- CR/CRi
研究概览
简要总结
The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.
详细描述
Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.
排除标准
- •Acute promyelocytic leukemia (AML subtype M3)
- •Previous exposure to the treatment of VEN-based regimen
- •Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- •Respiratory failure (PaO2 ≤60mmHg)
- •Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal [ULN], alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
- •Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate < 30 mL/min)
- •ECOG performance status 3, 4 or 5
- •Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision)
- •Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD is defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
- •Patients with pregnancy
- •Uncontrolled active infection
- •Clinically significant coagulation abnormalities
研究组 & 干预措施
VAH group
Patients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML.
干预措施: VAH regimen (Drug)
VEN+HMA group
Patients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML.
干预措施: VEN+HMA regimen (Drug)
结局指标
主要结局
CR/CRi
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Complete remission and CR with incomplete count recovery
次要结局
- MRD negative(At the end of Cycle 2 (each cycle is 28 days))
- Overall response(At the end of Cycle 2 (each cycle is 28 days))
- Overall survival(2 years)
- Event-free survival(2 years)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University