CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression

Giving CAR-T CD19 Transgenic T Cells for Acute Myeloid Leukemia Patients (AML) With t 8:21 and CD19 Expression

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.

Inclusion Criteria:

• 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 .

Exclusion Criteria:

• 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