A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in the Treatment of Adult Newly Diagnosed Early Precursor T-cell Acute Lymphoblastic Leukemia (ETP-ALL)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- 1-year EFS
研究概览
简要总结
ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥14 and <75 years old.
- •Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment.
- •Newly diagnosed patients.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival of ≥3 months.
- •Able to undergo oral treatment with venetoclax.
- •No organ dysfunction that would restrict the treatment administered
- •Understanding of the study and signing of the informed consent form.
- •Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
排除标准
- •Patients who are unable to take venetoclax by mouth;
- •Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases;
- •Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- •A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- •Serum total bilirubin >1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP >5 ULN; serum creatinine >1.5 ULN and creatinine clearance rate <40 mL/min; LVEF <50%;
- •Known HIV infection;
- •Known central nervous system leukemia infiltration;
- •Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator;
- •Inability to understand or comply with the study protocol.
研究组 & 干预措施
VHAG group
Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L
干预措施: Homoharringtonine (Drug)
VHAG group
Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L
干预措施: venetoclax (Drug)
VHAG group
Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L
干预措施: Cytarabine (Drug)
VHAG group
Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L
干预措施: G-CSF (Drug)
Traditional Chemotherapy Regimen group
- VDCLP regimen
- VD(/I) CP regimen
- Hyper CVAD-A regimen
- VDLP regimen
干预措施: Cytarabine (Drug)
Traditional Chemotherapy Regimen group
- VDCLP regimen
- VD(/I) CP regimen
- Hyper CVAD-A regimen
- VDLP regimen
干预措施: Vindesine (Drug)
Traditional Chemotherapy Regimen group
- VDCLP regimen
- VD(/I) CP regimen
- Hyper CVAD-A regimen
- VDLP regimen
干预措施: Daunorubicin (Drug)
Traditional Chemotherapy Regimen group
- VDCLP regimen
- VD(/I) CP regimen
- Hyper CVAD-A regimen
- VDLP regimen
干预措施: cyclophosphamide (Drug)
Traditional Chemotherapy Regimen group
- VDCLP regimen
- VD(/I) CP regimen
- Hyper CVAD-A regimen
- VDLP regimen
干预措施: Dexamethasone (Drug)
Traditional Chemotherapy Regimen group
- VDCLP regimen
- VD(/I) CP regimen
- Hyper CVAD-A regimen
- VDLP regimen
干预措施: L-ASP (Drug)
结局指标
主要结局
1-year EFS
时间窗: 1 year
1-year event free survival rate
次要结局
- OS(through study completion, up to 3 years)
- MRD(At the end of Cycle 1 (up to 42 days))
- Safety of induction therapy(At the end of Cycle 1 (up to 42 days))
- CR/CRi(At the end of Cycle 1 (up to 42 days))