Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant
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
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Jan 2008
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2007
Primary Completion Date
Dec 2008Actual
Completion Date
Dec 2008Actual
First Submitted Date
Dec 6, 2007
First Submission Date that Met QC Criteria
Dec 6, 2007
First Posted Date
Dec 7, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 25, 2013
Last Update Posted Date
Mar 26, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Asan Medical CenterOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Cancer
Keywords
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
chronic eosinophilic leukemia
primary myelofibrosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
18Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
therapeutic allogeneic lymphocytes
Biological
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks
No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
Bilirubin < 2.0 mg/dL
AST < 3 times upper limit of normal
Creatinine < 2.0 mg/dL
Ejection fraction > 40% on MUGA scan
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
65 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Kyoo H. Lee, MD
Asan Medical Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Korea Research Institute of Bioscience and Biotechnology
Dajeon
305-806
South Korea
Asan Medical Center - University of Ulsan College of Medicine