A Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of VAO Regimen in Patients With Newly Diagnosed Ph-positive Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete molecular remission（CMR）
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.
详细描述
This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax, azacitidine and orebatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.
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
- •Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-
- •Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
- •Creatinine clearance ≥ 30 mL/min.
- •Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.
- •Provide informed consent.
排除标准
- •Patients with another malignant disease.
- •Patients with uncontrolled active infection.
- •Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- •Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
- •Patients with uncontrolled active bleeding.
- •Patients who has participated or participating in other clinical trials related to this disease.
- •Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
- •Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
- •Patients with other commodities that the investigators considered not suitable for the enrollment.
研究组 & 干预措施
Venetoclax, Azacitidine, and Orebatinib Regimen
See Detailed Description.
干预措施: Venetoclax (Drug)
Venetoclax, Azacitidine, and Orebatinib Regimen
See Detailed Description.
干预措施: Azacitidine (Drug)
Venetoclax, Azacitidine, and Orebatinib Regimen
See Detailed Description.
干预措施: Orebatinib (Drug)
结局指标
主要结局
complete molecular remission（CMR）
时间窗: End of cycle 1 and 2 (each cycle is 28 days)
Proportion of patients achieving CMR at the end of 1 or 2 cycles
次要结局
- CR(End of cycle 1 and 2 (each cycle is 28 days))
- CCyR(End of cycle 1 and 2 (each cycle is 28 days))
- MMR(End of cycle 1 and 2 (each cycle is 28 days))
- Number of adverse events(End of cycle 1 and 2 (each cycle is 28 days))
- RFS(1 year)
- OS(1 year)
- CRi(End of cycle 1 and 2 (each cycle is 28 days))
- MRD-negative CR(End of cycle 1 and 2 (each cycle is 28 days))