Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant
RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back.
PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Donor Natural Killer Cell Infusion for the Prevention of Relapse or Graft Failure After HLA-Haploidentical Familial Donor Bone Marrow Transplantation-A Phase I Study|
- Maximum tolerated dose of donor natural killer (NK) cells [ Designated as safety issue: Yes ]
- Safety [ Designated as safety issue: Yes ]
- Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- To ascertain the safety of donor natural killer (NK) cells, generated from peripheral blood hematopoietic stem cells, when given as a single intravenous infusion in patients who have undergone HLA-haploidentical familial donor bone marrow transplantation (BMT).
- To determine the maximum tolerated dose of donor NK cells when given as a single infusion.
- To determine the effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor BMT.
OUTLINE: Patients receive donor natural killer cells as a single infusion over 1 hour.
Cohorts of 3-6 patients receive escalating doses of natural killer cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience grade III toxicities or acute graft-vs-host disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569283
|Korea, Republic of|
|Korea Research Institute of Bioscience and Biotechnology|
|Dajeon, Korea, Republic of, 305-806|
|Asan Medical Center - University of Ulsan College of Medicine|
|Seoul, Korea, Republic of, 138-736|
|Study Chair:||Kyoo H. Lee, MD||Asan Medical Center|