HLA-Haploidentical Hematopoietic Cell Transplantation and Subsequent Donor Natural Killer Cell Infusion in Refractory Acute Leukemia - A Phase 1-2a STUDY
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 effect.
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.
Patients who are pregnant or lactating are not eligible.
Type of Study:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
occurrence and severity of side effects of donor natural killer cell infusion
Outcome Time Frame:
Korea: Food and Drug Administration
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- acute myelogenous leukemia
- acute lymphoblastic leukemia
- donor natural killer cells
- HLA-haploidentical hematopoietic cell transplantation
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid