Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT00569283
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-07
• Status Verified: 2008-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of donor natural killer (NK) cells
Safety
Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation

Trial Locations

Locations (2)

Korea Research Institute of Bioscience and Biotechnology; 🇰🇷 Dajeon, Korea, Republic of

Asan Medical Center - University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of