NCT03685786Unknown1 期
The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)
Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
研究概览
简要总结
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
详细描述
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment
- •Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis
- •Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis
- •Age 14 years to 75 years
- •Adequate organ function defined as:
- •AST and ALT ≤ 3 times upper limit of normal range for age,
- •Serum creatinine ≤ 1.6 mg/dl,
- •Direct bilirubin ≤2.0 mg/dl,
- •Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
- •Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA.
- •Patients with CNS disease will be eligible if CNS disease is responsive to therapy
- •Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood
- •Adequate performance status defined as ECOG Performance Status 0 or 1
- •Provides written informed consent
- •Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol
排除标准
- •Active, uncontrolled infection
- •Active hepatitis B or hepatitis C
- •HIV Infection
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification
- •Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
- •Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
- •immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
研究组 & 干预措施
Experimental: CART19 cell and auto-HSCT
Experimental
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
干预措施: CART19 cell and auto-HSCT (Biological)
结局指标
主要结局
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
时间窗: day 28
The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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