Status:
UNKNOWN
Donor Immune Cell Therapy for Acute Myeloid Leukemia
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This study aims to introduce a new technology of donor NK cell infusion. NK cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors. In this study, NK...
Detailed Description
Primary end point: To determine the rate of overall survival at 2 years of Interventional cohort Secondary end point: To determine the cumulative incidence of relapse at 2 years. To determine the r...
Eligibility Criteria
Inclusion
- Patients must have been diagnosed as acute myeloid leukemia in accordance with "Chinese Diagnosis and Treatment Guidelines of AML". Those who achieved CR after chemotherapy are mainly included. Refractory/relapsed AML can also be enrolled.
- Patients with normal heart function (ejection fraction ≥ 50%), normal liver function(ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value) and normal renal function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol /L) can be enrolled.
- Patients will be required to sign an informed consent.
Exclusion
- Patients with severe infection or other malignant tumors.
- Women during pregnancy or lactation.
- Other patients deemed unsuitable by the investigator.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05333705
Start Date
July 1 2021
End Date
September 1 2024
Last Update
April 19 2022
Active Locations (1)
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1
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710016