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临床试验 NCT06361329 针对ETP-ALL目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL III期 81
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临床试验NCT06361329旨在研究治疗，主要针对ETP-ALL。这是一项III期 干预性研究试验，目前试验状态为招募中。试验始于2024年4月3日，计划招募81名患者。该研究由First Affiliated Hospital of Zhejiang University主导，预计于2027年3月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年2月17日。
简要概括
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 ...显示更多
官方标题
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)
疾病
ETP-ALL其他研究标识符
- 20240030C
NCT编号
实际开始日期
2024-04-03
最近更新发布
2025-02-17
预计完成日期
2027-03-31
计划入组人数
81
研究类型
干预性研究
试验分期 (阶段)
III期
试验状态
招募中
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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 | Homoharringtonine Intravenous infusion venetoclax Orally by mouth Cytarabine subcutaneous injection or Intravenous infusion G-CSF subcutaneous injection |
阳性对照Traditional Chemotherapy Regimen group * VDCLP regimen
* VD(/I) CP regimen
* Hyper CVAD-A regimen
* VDLP regimen | Cytarabine subcutaneous injection or Intravenous infusion Vindesine Intravenous infusion Daunorubicin Intravenous infusion cyclophosphamide Intravenous infusion Dexamethasone Intravenous infusion or orally L-ASP subcutaneous injection |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
1-year EFS | 1-year event free survival rate | 1 year |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
CR/CRi | Complete remission/complete remission with incomplete count recovery | At the end of Cycle 1 (up to 42 days) |
OS | Overall survival | through study completion, up to 3 years |
MRD | Percentage of participants who converted to MRD \< 10\^-3 after the first cycle of treatment. | At the end of Cycle 1 (up to 42 days) |
Safety of induction therapy | Adverse events | At the end of Cycle 1 (up to 42 days) |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
14 Years
适龄性别
全部
- 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 0-2.
- 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.
- 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.
First Affiliated Hospital of Zhejiang University没有联系数据。
1 位于 1 个国家/地区的研究中心
Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China
Jie Jin, PhD&MD, 联系人, 13705716779, [email protected]
招募中