Giving CAR-T CD19 Transgenic T Cells for Acute Myeloid Leukemia Patients (AML) With t 8:21 and CD19 Expression
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The change in the chromosomal translocations and aberrations
研究概览
简要总结
Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel.
However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia.
The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 .
排除标准
- •Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45%
- •Active involvement of CNS
- •Active infection
- •Pregnancy or lactation
- •Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment
- •A positive result for the HIV infection (serum)
- •Active hepatitis infection
- •Life-threatening allergies to cyclophosphamide or fludarabine
- •No informed consent signed by candidate
- •Candidate enrolled in other study
研究组 & 干预措施
Cyclophosphamide, Flodarabine,CAR-T cells
The appropriate participants will undergo lymhopheresis to collect lymphocytes from PBMC peripheral blood. CAR T CD19 cells will be produced. The participants will receive cyclophosphamide 300 mg / m² and flodarabine 30 mg / m² lymphodeplition intravenously daily for 3 days.
The CAR-T CD19 cells will be given on the 5 to 7 day post lymphodeplition .
干预措施: CAR-T CD19 (Biological)
结局指标
主要结局
The change in the chromosomal translocations and aberrations
时间窗: Within two years from the introduction of the CAR-T CD19
Will be evaluated by cytogenetics and FISH
The change in the peripheral blood counts and differential
时间窗: Within two years from the introduction of the CAR-T CD19
Will be evaluated by Coulter counter
The change in the measurable residual disease
时间窗: Within two years from the introduction of the CAR-T CD19
Will be evaluated by PCR
The change in the antigen expression on the leukemic blasts
时间窗: Within two years from the introduction of the CAR-T CD19
Will be evaluated by FACS
次要结局
未报告次要终点
研究者
Prof Arnon Nagler
M.D., M.Sc, Professor of Medicine Tel Aviv University, Director Hematology Division, Chaim Sheba Medical Center
Sheba Medical Center