A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Jing Wang
- 电话号码：8621-61009600
- 邮箱：jwang@maxinovel.com
学习地点
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Tianjin、中国
- 招聘中
- Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
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接触：
- jianxiang Wang, MD
- 电话号码：86-22-23909278
- 邮箱：wangjx@ihcams.ac.cn
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
1. Patients meeting the World Health Organization (WHO) 2016 diagnostic criteria for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy:
- Age ≥65 years, or
- Age >18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:
ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL/min but ≤45 mL/min (Cockcroft-Gault)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval) 2. No prior AML therapy, except:Hydroxyurea. 3. ECOG performance status ≤3 4. Laboratory requirements: WBC≤3×10*9/L、AST/ALT/ALP ≤3×ULN (except: due to leukemic involvement)、Total bilirubin ≤1.5×ULN、Serum creatinine clearance ≥30 mL/min (measured or calculated) 5. Life expectancy ≥3 months 6. Contraception requirements: Negative pregnancy test for women of childbearing potential；Agreement to use effective contraception during treatment and for 6 months after therapy
Exclusion Criteria:
- AML with BCR::ABL1 fusion、Acute promyelocytic leukemia (APL).
- Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN).
- Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation.
- Hypersensitivity to any study drugs.
- Active malignancy in other organs (requiring treatment).
- Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled/symptomatic congestive heart failure (NYHA Class >2)
- Active infections, including:Untreated tuberculosis or any aspergillosis.
- Known HIV, active hepatitis B (HBV), or hepatitis C (HCV).
- Central nervous system (CNS) leukemia at baseline.
- Conditions limiting oral drug absorption (e.g., malabsorption syndrome).
- Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance.
- Investigator's discretion for ineligibility.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML
Patients in dose escalation stage received oral MAX-40279 at 40 mg, 50 mg, and 60 mg twice daily (BID), in combination with VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7) in 28-day cycles. Patients in dose expansion stage received RP2D MAX-40279 plus VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7). |
Dose escalation：MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.
Given by IV, 75 mg/m2
其他名称：
100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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DLT
大体时间：Dose escalation; an average of 6 months.
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The dose limiting toxicities, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Dose escalation; an average of 6 months.
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Adverse events (AEs), serious adverse events (SAEs)
大体时间：Through study completion; an average of 24 months.
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Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Through study completion; an average of 24 months.
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Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
大体时间：Dose escalation; an average of 6 months.
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Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Dose escalation; an average of 6 months.
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CRc
大体时间：Through study completion; an average of 24 months.
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complete remission rate
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Through study completion; an average of 24 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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RFS
大体时间：Through study completion; an average of 8 months.
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Recurrence-Free Survival
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Through study completion; an average of 8 months.
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DoR
大体时间：Through study completion; an average of 8 months.
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duration of response
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Through study completion; an average of 8 months.
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OS
大体时间：Through study completion; an average of 24 months.
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overall survival
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Through study completion; an average of 24 months.
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合作者和调查者
调查人员
- 首席研究员：Jianxiang Wang, MD、Institute of Institute of Hematology & Blood Diseases Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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