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

Sheba Medical Center10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

CAR-T CD19BIOLOGICAL

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chaim Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Outcomes

Primary Outcomes

The change in the peripheral blood counts and differential

Will be evaluated by Coulter counter

Time frame: Within two years from the introduction of the CAR-T CD19

The change in the antigen expression on the leukemic blasts

Will be evaluated by FACS

Time frame: Within two years from the introduction of the CAR-T CD19

The change in the measurable residual disease

Will be evaluated by PCR

Time frame: Within two years from the introduction of the CAR-T CD19

The change in the chromosomal translocations and aberrations

Will be evaluated by cytogenetics and FISH

Time frame: Within two years from the introduction of the CAR-T CD19

Central Contacts

Arnon Nagler, MD

CONTACT

+972-3-530 5830 Arnon.Nagler@sheba.health.gov.il

Data from ClinicalTrials.gov

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