Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.
详细描述
The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied. Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy. The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders. Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy. Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo AML patients;
- •Age ≥ 18 years and ≤ 60 years;
- •AML with ELN2022-low risk
- •Received 1-3 cycles of HDAC consolidation therapy
- •HGB 60-90 G/L
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- •Life expectancy ≥ 3 months;
- •Signed informed consent and able to understand and comply with the procedures required by this protocol.
排除标准
- •Concurrent myelofibrosis
- •Patients unresponsive to red blood cell transfusions
- •Heart function < grade 2
- •Renal function: creatinine clearance < 30 ml/min
- •Liver function: ALTd > 5 times normal, bilirubin > 3 times normal
- •Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
- •History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
- •Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection
- •History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
- •Pregnant or breastfeeding women
- •Patients deemed unsuitable for enrollment by the investigators
研究者
Qing Zhang
Chief Physician
Guangdong Second Provincial General Hospital