A Phase Ⅱ, Open Label, Single Arm, Single-Center Study to Evaluate the Efficacy and Safety of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CMR
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.
详细描述
This is a phase Ⅱ, open-label, single-arm, single-center study in newly diagnosed Ph-positive acute leukemia and CML-AP/BP patients. The patients will receive azacitidine, venetoclax, and flumatinib 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP 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.
- •No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax.
- •Provide informed consent.
排除标准
- •Patients with another malignant disease.
- •Patients has participated in or participating in other clinical trials.
- •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 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
Azacitidine，Venetoclax，and Flumatinib Regimen
See Detailed Description.
干预措施: Flumatinib (Drug)
Azacitidine，Venetoclax，and Flumatinib Regimen
See Detailed Description.
干预措施: Azacitidine (Drug)
Azacitidine，Venetoclax，and Flumatinib Regimen
See Detailed Description.
干预措施: Venetoclax (Drug)
结局指标
主要结局
CMR
时间窗: End of cycle 2 (each cycle is 28 days)
Complete molecular remission (CMR) was defined as undetectable BCR/ABL transcript.
次要结局
- RFS(2 years)
- CR/CRi, MRD-negative CR, CCyR, 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))
- OS(2 years)