A Multicenter, Prospective, Single-arm Clinical Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of Refractory/Relapsed Acute Myeloid Leukemia (R/R AML)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete remission rate (CR)
研究概览
简要总结
To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).
详细描述
- Sogletanib 48mg per dose, once daily; Venetoclax 400mg per dose, once daily for 4 weeks; Azacitidine 100mg, once daily, days 1-7. 28 days/cycle, at least 2 cycles.
- The drug concentration of Venetoclax will be tested one week after oral administration, and the dose will be adjusted according to the concentration.
- After 2 treatment courses, patients with stable disease (SD) or progressive disease (PD) may receive up to 1-2 additional courses. If the disease still shows no improvement, they will be withdrawn from the clinical study and other treatment options will be considered, including allogeneic hematopoietic stem cell transplantation.
Note: In special circumstances based on the patient's condition, laboratory test indicators, and adverse reactions, etc.; for Venetoclax dosage, if the white blood cell count is >25×10^9/L before administration, hydroxyurea may be given first to reduce the count to less than 25×10^9/L before adding Venetoclax, and then the concentration of Venetoclax will be tested and the dose adjusted according to the concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myeloid leukemia (AML) confirmed by histology. Relapsed or refractory AML, including: a) Refractory disease is defined as no remission after at least one prior treatment. b) Disease relapse is defined as 5% or more blasts in the bone marrow after remission. c) Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, t-AML) are also eligible;
- •Age ≥18 years, male or female, with an expected survival of more than 3 months;
- •Estimated creatinine clearance ≥ 50 mL/min;
- •AST and ALT ≤ 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin ≤ 3.0 x ULN (unless considered due to leukemia organ involvement);
- •Subjects are non-pregnant or using contraceptive measures during treatment;
- •Capable of understanding and voluntarily providing informed consent.
排除标准
- •Acute promyelocytic leukemia (APL);
- •Active central nervous system leukemia;
- •Patients with clinically significant QTc interval prolongation (males > 450 ms; females > 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within the year prior to enrollment, and patients with clinically symptomatic coronary heart disease requiring medication;
- •Active, uncontrolled severe infection;
- •Other non-myeloid malignancies within the past 2 years;
- •Mental disorders that would impede study participation;
- •Previous solid organ transplantation (pre-treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppressive/GVHD treatment);
- •Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.
研究组 & 干预措施
CVA
Chiglitazar Sodium in combination with Venetoclax and Azacitidine
干预措施: CVA (Drug)
结局指标
主要结局
Complete remission rate (CR)
时间窗: Up to 36 months
The absolute neutrophil count is ≥1.0 × 10\^3/μL, the platelet count is ≥1.0 × 10\^5/μL, independent of red blood cell transfusions, and the percentage of bone marrow blasts is \<5%. There are no circulating bone marrow blasts and blasts with Auer rods in the peripheral blood; no extramedullary disease is present.
Complete Remission with Incomplete Count Recovery (CRi)
时间窗: Up to 36 months
Meeting all CR criteria except for residual neutropenia \<1.0 × 10\^3/μL (1000/μL) or thrombocytopenia \<1.0 × 10\^5/μL (100,000/μL). Dependence on red blood cell (RBC) transfusions is also defined as CRi.
Partial remission rate (PR)
时间窗: Up to 36 months
Meets all hematological criteria for CR, but the percentage of blasts in the bone marrow aspirate sample has decreased by at least 50%, reaching between 5% and 25%.
次要结局
未报告次要终点
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University