NCT07238907进行中（未招募）不适用
A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
This multi-center retrospective study aims to evaluate the efficacy and safety of inotuzumab ozogamicin in adults B-ALL of different subgroups. This study is a retrospective study. Data will be collected from Electronic Medical Record, interventions will not be implemented on patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between ≥16 and ≤80 years at screening, no gender restrictions
- •Be diagnosed with B-ALL
- •Appropirate organ function, meeting the following criteria:
- •Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) ≤3 times ULN;
- •Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);
- •Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula);
- •Left ventricular ejection fraction (LVEF) ≥50%;
排除标准
- •Active infection at screening.
- •Any of the following cardiac conditions:
- •NYHA Class III or IV congestive heart failure;
- •Severe arrhythmia requiring treatment;
- •Uncontrolled hypertension or pulmonary hypertension despite standard therapy;
- •Unstable angina;
- •Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion;
- •Clinically significant valvular disease;
- •Other cardiac conditions deemed unsuitable by the investigator;
- •History of epilepsy, cerebellar disease, or other active central nervous system disorders;
- •History of hypersensitivity to any component of the investigational product.
- •Life expectancy of less than three months;
- •Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
研究组 & 干预措施
observation group
干预措施: Inotuzumab Ozogamicin (Drug)
结局指标
主要结局
overall response rate
时间窗: Till the end of the study, up to 12 months
The proportion of patients who reach CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
次要结局
- minimal residual disease negativity rate(Till the end of the study, up to 12 months)
- overall survival(Till the end of the study, up to 12 months)
- Relapse-free survival(Till the end of the study, up to 12 months)
- Hematological toxicity: neutropenia, thrombocytopenia, febrile neutropenia, anemia, bone marrow suppression Non hematological toxicity: SOS,TLS, peripheral edema, fever, fatigue, MODS, infection, liver dysfunction, renal dysfunction et al.(Till the end of the study, up to 12 months)
研究者
Jin Wang
chief physician, MD, PhD
Ruijin Hospital
研究点 (1)
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