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

Primary Purpose

Acute Myeloid Leukemia

Status

Recruiting

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

CAR-T CD19

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Chimeric antigen receptors; Mixed phenotype acute leukemia; T cells.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chaim Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamide, Flodarabine,CAR-T cells

Arm Description

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 .

Outcomes

Primary Outcome Measures

The change in the peripheral blood counts and differential

Will be evaluated by Coulter counter

The change in the antigen expression on the leukemic blasts

Will be evaluated by FACS

The change in the measurable residual disease

Will be evaluated by PCR

The change in the chromosomal translocations and aberrations

Will be evaluated by cytogenetics and FISH

Secondary Outcome Measures

Full Information

NCT ID

NCT04257175

First Posted

January 20, 2020

Last Updated

October 30, 2022

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04257175

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2020 (Actual)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

Chimeric antigen receptors; Mixed phenotype acute leukemia; T cells.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cyclophosphamide, Flodarabine,CAR-T cells

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

CAR-T CD19

Intervention Description

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).

Primary Outcome Measure Information:

Title

The change in the peripheral blood counts and differential

Description

Will be evaluated by Coulter counter

Time Frame

Within two years from the introduction of the CAR-T CD19

Title

The change in the antigen expression on the leukemic blasts

Description

Will be evaluated by FACS

Time Frame

Within two years from the introduction of the CAR-T CD19

Title

The change in the measurable residual disease

Description

Will be evaluated by PCR

Time Frame

Within two years from the introduction of the CAR-T CD19

Title

The change in the chromosomal translocations and aberrations

Description

Will be evaluated by cytogenetics and FISH

Time Frame

Within two years from the introduction of the CAR-T CD19

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arnon Nagler, MD

Phone

+972-3-530 5830

Arnon.Nagler@sheba.health.gov.il

Facility Information:

Facility Name

Chaim Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

57261

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnon Nagler, M.D.

First Name & Middle Initial & Last Name & Degree

M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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