NCT07236931已完成不适用
Clinical Study of Selinexor-Based Chemotherapy With Minimal or No Cytotoxic Agents in Treatment-Naïve AML Patients Unsuitable for Intensive Therapy: Focusing on Rapid Reduction of Blast Cells
Donghua Zhang1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. The investigation will focus on dynamic blast clearance patterns and early toxicity profiles to inform timely treatment adaptation during the critical induction window.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy .①Patients deemed ineligible for intensive chemotherapy must meet the following criteria: Age 18 to 74 years with at least one of the following comorbidities; Eastern Cooperative Oncology Group (ECOG) performance status ≥3; Cardiac history requiring treatment for congestive heart failure; Left ventricular ejection fraction ≤50%; Chronic stable angina; Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; Creatinine clearance ≥30 mL/min to <45 mL/min (Cockcroft-Gault formula); Moderate hepatic impairment: total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN); ②Other investigator-assessed comorbidities that preclude safe administration of intensive chemotherapy.
- •Hepatic function must meet the following criteria: Aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3.0 × ULN; Total bilirubin ≤3.0 × ULN. (unless deemed attributable to leukemic organ involvement)
- •Renal function must meet the following criterion: Creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula.
- •No history of drug allergies within the protocol.
- •Participants with plans for pregnancy must agree to use contraception before enrollment in the study and for six months after the study ends. If a participant becomes pregnant or suspects pregnancy, she must immediately notify the investigator.
- •The participant understands and signs the informed consent form.
排除标准
- •A definitive diagnosis of Acute Promyelocytic Leukemia (APL).
- •Age <18 years or ≥75 years.
- •The participant has previously received any treatment for acute myeloid leukemia (AML), except for hydroxyurea.
- •Uncontrolled active infections (including bacterial, fungal, or viral infections) that are clinically significant and refractory to medical therapy.
- •Currently participating in another clinical study or planning to initiate treatment in this study within less than 4 weeks after the completion of therapy in a prior clinical study.
- •Patients who have other malignancies that require treatment.
- •A history of allergy to the study drugs.
- •Female participants who are pregnant or breastfeeding.
- •Human immunodeficiency virus (HIV) infection or syphilis infection.
- •Active hepatitis that remains uncontrolled despite active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid [HBV DNA] or hepatitis C virus ribonucleic acid [HCV RNA]).
- •Patients with persistent positivity for Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 (excluding those who have transitioned from positive to negative).
- •Conditions that the investigator considers may increase the risk to participants or interfere with the study results.
- •Other conditions that the investigator deems the participant unsuitable for enrollment in this study.
研究组 & 干预措施
Experimental group
Experimental
selinexor (X), azacitidine (A), and venetoclax (B) - the XAB regimen
干预措施: the XAB regimen (Drug)
结局指标
主要结局
Overall survival
时间窗: 1，3，6，12，18，24 months after treatment
次要结局
未报告次要终点
研究者
Donghua Zhang
professor
Tongji Hospital
研究点 (1)
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