NCT07586735招募中不适用
A Novel Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplant in Patients Aged ≥ 40 Years Old With Severe Aplastic Anemia: a Multicenter, Single-arm, Observational Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Faliure free survival (FFS)
研究概览
简要总结
The goal of this prospective, multicenter, single arm observational study is to evaluate the efficacy and safety of the BFCA regimen in ≥ 40 years old SAA patients undergoing haplo-HSCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aplastic anemia;
- •Aged 40-60 years old;
- •Weight 45Kg-100Kg;
- •Eastern Cooperative Oncology Group (ECOG) score ≤3;
- •No major organ injury (ECG ejection fraction >45%; bilirubin < 2 times the upper limit of normal value; AST and ALT < 3 times the upper limit of normal value; serum creatinine < 2 times the upper limit of normal value);
- •No severe infection;
- •Subjects voluntarily participated in this clinical trial and signed the informed consent.
排除标准
- •With other hematologic diseases;
- •Expected survival of less than 1 month;
- •Previous autologous or allogeneic hematopoietic stem cell transplantation;
- •Pregnant patients;
- •Patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events;
- •Other conditions that the investigator determines to be inappropriate for enrollment.
- •Current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection
- •A history of symptomatic herpes zoster infection within 12 weeks prior to screening
- •Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- •Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB
- •Exposure to a live vaccine within 12 weeks prior to enrollment or expected to receive a live vaccine during the study
- •Clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled
- •Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
- •A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data
- •Any of the following specific abnormalities on screening laboratory tests:
- •ALT or AST >2 x ULN, or total bilirubin ≥1.5 x ULN
- •hemoglobin <9 g/dL, or total white blood cell (WBC) count <2,500/µL, or neutropenia (absolute neutrophil count <1,200/µL), or lymphopenia (lymphocyte count <750/µL)
- •eGFR <50 mL/min/1.73 m2
结局指标
主要结局
Faliure free survival (FFS)
时间窗: From enrollment to 2 years post-HSCT
survival with a response to therapy after HSCT. Death, graft faliue and relapse were considered as treatment failure.
次要结局
- The incidence of graft versus host disease(GVHD)(100 days post HSCT for aGvHD and 2 years post HSCT for cGvHD)
- The incidence of Cytomegalovirus(CMV) and Epstein-Barr virus(EBV) reactivation(180 days post HSCT)
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital
研究点 (1)
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