Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation (DNKI-II)
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|ClinicalTrials.gov Identifier: NCT01795378|
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : December 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia||Biological: donor natural killer cell infusion||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HLA-Haploidentical Hematopoietic Cell Transplantation and Subsequent Donor Natural Killer Cell Infusion in Refractory Acute Leukemia - A Phase 1-2a STUDY|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
- Biological: donor natural killer cell infusion
- Donor NK cells will be generated at the GCP laboratory at Asan Institute of Life Science by a team from Stem Cell Research Center, Korea Research Institute of Bioscience and Biotechnology.
- The patients will receive donor NK cell infusion (DNKI) around on days 6 and 9 (generated from the first collection), and around on days 13 and 20 (generated from the second collection).
- For DNKI to be given on days 6 and 9, a 3-patient cohort each will receive escalating dose of 2x10e7/kg, 5x10e7/kg, 1x10e8/kg, and 1-4 x10e8 cells.
- The dose of DNKI to be given on days 13 and 20 will be 1-4 x10e8/kg.
- occurrence and severity of side effects of donor natural killer cell infusion [ Time Frame: 1 year ]
- anti-leukemia effect of donor natural killer cell infusion [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795378
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|