Cancer Clinical Trial
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
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Primary Purpose: Treatment
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