Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation
NCT ID: NCT01795378
Last Updated: 2015-12-31
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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COMPLETED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2013-02-28
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Patients should not have excessive renal dysfunction (creatinine less than 3.0 mg/dl).
Patients should not have clinically-evident cardiac or pulmonary dysfunction. Patients and donors must sign informed consent.
Exclusion Criteria
17 Years
ALL
No
Sponsors
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Korea Research Institute of Bioscience & Biotechnology
OTHER_GOV
Asan Medical Center
OTHER
Responsible Party
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Kyoo-Hyung Lee
Professor
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.
Yoon SR, Lee YS, Yang SH, Ahn KH, Lee JH, Lee JH, Kim DY, Kang YA, Jeon M, Seol M, Ryu SG, Chung JW, Choi I, Lee KH. Generation of donor natural killer cells from CD34(+) progenitor cells and subsequent infusion after HLA-mismatched allogeneic hematopoietic cell transplantation: a feasibility study. Bone Marrow Transplant. 2010 Jun;45(6):1038-46. doi: 10.1038/bmt.2009.304. Epub 2009 Nov 2.
Other Identifiers
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AMC 2012-0478
Identifier Type: -
Identifier Source: org_study_id