Status:
COMPLETED
MG4101 for Refractory or Relapsed AML
Lead Sponsor:
Seoul National University Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is a single center, single arm, open-labeled phase 2 clinical study. The aim of this study is to investigate the efficacy and safety of allogeneic natural killer cell (MG4101). After lympho...
Detailed Description
Acute myeloid leukemia is a hematologic malignancy of myeloid lines leukocyte. In Korea, acute leukemia accounts for 87% of all leukemia and the incidence of acute myeloid leukemia is twice as high as...
Eligibility Criteria
Inclusion
- Age between 18 to 65
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2
- Informed consent
- Diagnosed with acute myeloid leukemia by 2016 WHO criteria
- Failure to achieve complete remission after the second line of standard chemotherapy
- Relapse after the second line of standard chemotherapy and not eligible for the allogeneic stem cell transplantation
- Adequate major organ function
Exclusion
- Acute promyelocytic leukemia
- Central nervous system involvement of the leukemia
- Hypersensitivity to IL-2
- Previous cell therapy
- Impaired major organ function
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03349502
Start Date
November 1 2017
End Date
April 30 2020
Last Update
April 18 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080