Status:
COMPLETED
Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Korea Research Institute of Bioscience & Biotechnology
Conditions:
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
17+ years
Phase:
PHASE1
PHASE2
Brief Summary
The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after HLA-mismatched hematopoietic cell transplantation.
Detailed Description
Those patients with acute leukemia, which is not responding to coventional chemotherapy, will be treated. The clinical effects will be evaulated in terms of safety (side effects) and anti-leukemia eff...
Eligibility Criteria
Inclusion
- Patients with acute leukemia, which are refractory to standard treatment. Patients should be 17 years of age or older. The performance status of the patients should be 70 or over by Karnofsky scale. Patients should not have excessive hepatic dysfunction (bilirubin less than 3.0 mg/dl, AST less than 5 times the upper normal limit).
- 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
- Patients who are pregnant or lactating are not eligible.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01795378
Start Date
February 1 2013
End Date
May 1 2015
Last Update
December 31 2015
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736