CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression
NCT ID: NCT04257175
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2020-02-18
2024-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cyclophosphamide, Flodarabine,CAR-T cells
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 .
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof Arnon Nagler
M.D., M.Sc, Professor of Medicine Tel Aviv University, Director Hematology Division, Chaim Sheba Medical Center
Locations
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Chaim Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Arnon Nagler, M.D.
Role: primary
M.D.
Role: backup
Other Identifiers
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6482-19-SMC
Identifier Type: -
Identifier Source: org_study_id