Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant
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|ClinicalTrials.gov Identifier: NCT00569283|
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : March 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: therapeutic allogeneic lymphocytes||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- Maximum tolerated dose of donor natural killer (NK) cells
- Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|