NCT06537843招募中2 期
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia: Multicenter, Phase 2, Clinical Trial
Hospital Municipal São José5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.
详细描述
Subjects will be included voluntarily after informed consent. Diagnosis of AML in accordance with the WHO classification and determination of inegibility to induction therapy or refractory or relapsed disease after initial treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML in accordance with the World Health Organization criteria.
- •Ineligibility for induction chemotherapy due to age (≥ 70 years) or, for patients 18 to 74 years of age, ECOG-PS 2 or 3, creatinine clearance below 60 mL/min/1,73m², left ventricular ejection fraction ≤ 50%.
- •Projected life expectancy of at least 12 weeks.
- •Not requiring supplemental oxygen or substitutive renal therapy.
- •Female participants must be either postmenopausal, surgically sterile or practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
- •Male participants must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception and to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
- •Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
排除标准
- •Diagnosis of acute promyelocytic leukemia (APL).
- •Known central nervous system (CNS) involvement with AML.
- •Known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or other active viral, bacterial or fungal infection requiring treatment.
- •History of other malignancies prior to study entry, with the exception of non-melanoma skin cancer.
- •Chronic Liver Disease and Cirrhosis with a class B or C Child-Pugh score.
研究组 & 干预措施
VenCM
Experimental
Venetoclax, Cytarabine, Metformin
干预措施: Venetoclax (Drug)
VenCM
Experimental
Venetoclax, Cytarabine, Metformin
干预措施: Cytarabine Injection (Drug)
VenCM
Experimental
Venetoclax, Cytarabine, Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 12 months and 24 months
Overall survival is defined as the time from patient inclusion to the date of death, using Kaplan-Meier methodology.
次要结局
- Composite Complete Response Rate (CCR)(12 months and 24 months)
- Negative Measurable Residual Disease (MRD) Rate(12 months and 24 months)
研究者
Marcelo Pitombeira de Lacerda
MD, PhD, Hematology Specialist
Hospital Municipal São José
研究点 (5)
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