Trial | NCT01795378  Report issue

Title

Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation
HLA-Haploidentical Hematopoietic Cell Transplantation and Subsequent Donor Natural Killer Cell Infusion in Refractory Acute Leukemia - A Phase 1-2a STUDY

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after HLA-mismatched hematopoietic cell transplantation.
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.
Study Started
Feb 28
2013
Primary Completion
May 31
2015
Study Completion
May 31
2015
Last Update
Dec 31
2015
Estimate

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.

Criteria 

Inclusion Criteria:

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 Criteria:

Patients who are pregnant or lactating are not eligible.
No Results Posted