Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.
详细描述
This is a phase II/III study that seeks to treat patients ages 18-60 who have acute myeloid leukemia but have never been treated before. In order to improve the outcome of patients with primary AML, venetoclax combined with homoharringtonine and cytarabine was applied in the treatment of primary AML. This study aims to evaluate the efficacy and safety of venetoclax in combination with homoharringtonine and cytarabine in newly diagnosed subjects with AML.Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
- •patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
- •Patients > 18 to ≤ 60 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
- •Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count < 25 × 109 /L (hydroxyurea is permitted to meet this criterion)
排除标准
- •> 60 years of age or <18 years of age
- •Acute promyelocytic leukemia (M3)
- •Patient is ineligible for treatment with intensive chemotherapy
- •Patient with active infection not controlled, active bleeding from vital organs
- •Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
- •Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
- •Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.
- •Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
- •Patients deemed unsuitable for enrolment by the investigator.
研究组 & 干预措施
Venetoclax Combined With Homoharringtonine and Cytarabine
All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.
干预措施: Venetoclax (Drug)
Venetoclax Combined With Homoharringtonine and Cytarabine
All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.
干预措施: Homoharringtonine (Drug)
Venetoclax Combined With Homoharringtonine and Cytarabine
All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.
干预措施: Cytarabine (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 28 days after study treatment
Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).
次要结局
- Rate of Participants With Adverse Events(Through 28 days post study medication administration)
- Event-free survival(Through study completion, up to 3 years)
- Overall survival(Through study completion, up to 3 years)