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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257175
• Other study ID #: 6482-19-SMC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 18, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Sheba Medical Center
• Contact: Arnon Nagler, MD
• Phone: +972-3-530 5830
• Email: Arnon.Nagler[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• CAR-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).

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the peripheral blood counts and differential	Will be evaluated by Coulter counter	Within two years from the introduction of the CAR-T CD19
Primary	The change in the antigen expression on the leukemic blasts	Will be evaluated by FACS	Within two years from the introduction of the CAR-T CD19
Primary	The change in the measurable residual disease	Will be evaluated by PCR	Within two years from the introduction of the CAR-T CD19
Primary	The change in the chromosomal translocations and aberrations	Will be evaluated by cytogenetics and FISH	Within two years from the introduction of the CAR-T CD19