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

NCT04257175 | Unknown Phase 2

• 1 other identifier: 6482-19-SMC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• The change in the measurable residual disease

  Will be evaluated by PCR

  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

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

Study Arms (1)

Cyclophosphamide, Flodarabine,CAR-T cells

EXPERIMENTAL

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 .

Biological: CAR-T CD19

Interventions

CAR-T CD19 BIOLOGICAL

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).

Cyclophosphamide, Flodarabine,CAR-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, 57261, Israel

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Biphenotypic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Arnon Nagler, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc, Professor of Medicine Tel Aviv University, Director Hematology Division, Chaim Sheba Medical Center

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 5, 2020
• Study Start: February 18, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

IL (1)