Acute Myeloid Leukemia
Conditions
Keywords
Chimeric antigen receptors; Mixed phenotype acute leukemia; T cells.
Brief summary
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.
Interventions
BIOLOGICALCAR-T CD19
The CAR-T infusion will be given in IV infusion. The target dose is 1 X 106 positive CAR / kg T cells (range: 0.5-1.5X 106 CAR / kg positive T cells).
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the peripheral blood counts and differential | Within two years from the introduction of the CAR-T CD19 | Will be evaluated by Coulter counter |
| The change in the antigen expression on the leukemic blasts | Within two years from the introduction of the CAR-T CD19 | Will be evaluated by FACS |
| The change in the measurable residual disease | Within two years from the introduction of the CAR-T CD19 | Will be evaluated by PCR |
| The change in the chromosomal translocations and aberrations | Within two years from the introduction of the CAR-T CD19 | Will be evaluated by cytogenetics and FISH |
Countries
Israel
Contacts
Primary ContactArnon Nagler, MD
Outcome results
None listed