Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）
NCT ID: NCT04534634
Last Updated: 2020-09-01
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2019-04-01
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
IFN-α combined with CAR T-cells therapy
IFN-α combined with CAR-T cell therapy
Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle.
Children: 14 daily intramuscular injections 200mg/m\^2 of Interferon-α for a 28-day cycle.
CAR T cell: (1-2)×10\^7/kg, intravenously infusion.
Control group
CAR T-cells therapy
No interventions assigned to this group
Interventions
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IFN-α combined with CAR-T cell therapy
Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle.
Children: 14 daily intramuscular injections 200mg/m\^2 of Interferon-α for a 28-day cycle.
CAR T cell: (1-2)×10\^7/kg, intravenously infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 12-65.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. Target on leukemia is \>20% positive detected with flowcytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
6.No other immunotherapy was received within 3 months.
Exclusion Criteria
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.
12 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Xiaowen Tang
Chief Physician
Principal Investigators
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xiaowen tang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IFN-α+CAR-T
Identifier Type: -
Identifier Source: org_study_id
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