Selecting a Favorable KIR Donor in Unrelated HCT for AML
This study is currently recruiting participants.
Verified March 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborator:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01288222
First received: February 1, 2011
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD) hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically, donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect. This study proposes to prospectively test and validate the utility and effectiveness of further informing URD identification and selection by KIR genotyping as a supplement to HLA matching and the other variables known or suspected to indicate the best URD for a patient.
Hypotheses:
- Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML.
- Directed study procedures for rapid KIR genotyping and reporting to searching Transplant Centers (TC) can inform donor search and selection without delay in donor availability for HCT.
| Condition | Intervention |
|---|---|
|
Acute Myelogenous Leukemia |
Biological: KIR genotype Biological: Unrelated donor transplant |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor |
Resource links provided by NLM:
Further study details as provided by Masonic Cancer Center, University of Minnesota:
Primary Outcome Measures:
- Incidence of Relapse [ Time Frame: 2 Years ] [ Designated as safety issue: No ]To measure the impact of donor selection for KIR genotype in allogeneic URD HCT for AML on cumulative incidence of relapse. We will determine a quantitative estimate of the likelihood of better KIR donors identified with routine, non-directed donor selection along with KIR genotyping data. The observed incidence of success in a better KIR donor identified within 8 weeks will be compared to the original donor genotype expected frequencies identified in our retrospective genotyping of 1086 donors selected for AML transplants.
Secondary Outcome Measures:
- Incidence of Relapse-Free Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Incidence of Engraftment [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Incidence of Graft Versus Host Disease [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
- Incidence of Transplant Related Mortality [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]Number of patients who died within 2 years of transplant.
| Estimated Enrollment: | 800 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Unrelated Donor Transplant Patients
Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.
|
Biological: KIR genotype
KIR genotype from unrelated donor.
Biological: Unrelated donor transplant
hematopoietic cell transplant performed per each center's guidelines
Other Name: bone marrow transplant
|
Detailed Description:
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patient with acute myeloid leukemia (AML) undergoing screening for potential URD HCT
- Potential URD undergoing screening to provide a HCT graft to a patient with acute myeloid leukemia (AML) at a participating institution
- Provides written consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288222
Contacts
| Contact: Daniel Weisdorf, M.D. | 612-624-0123 | weisd001@umn.edu |
| Contact: Judy Witte, R.N. | 612-626-0169 | mirab001@umn.edu |
Locations
| United States, Arizona | |
| Mayo Clinic - Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: James Slack, MD slack.james@mayo.edu | |
| Principal Investigator: James Slack, MD | |
| United States, Colorado | |
| Colorado Blood Cancer Institute | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Mark Bruvand, MD 720-754-4800 mark.brunvand@healthonecares.com | |
| Principal Investigator: Mark Brunvand, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Edmund K. Wallter, MD 404-727-4995 ewaller@emory.edu | |
| Contact: Amelia Langston, MD amelia.langston@emoryhealthcare.org | |
| Principal Investigator: Edward K. Waller, MD | |
| United States, Illinois | |
| University of Chicago Medical Center Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Koen van Besien, MD 773-702-6149 kvbesien@medicine.bsd.uchicago.edu | |
| Principal Investigator: Koen van Besien, MD | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Sherif Farag, MD 317-274-0843 ssfarag@iupui.edu | |
| Principal Investigator: Sherif Farag, MD | |
| United States, Kansas | |
| Kansas University Cancer Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Joseph McGuirk, MD 913-588-6029 jmcguirk@kumc.edu | |
| Principal Investigator: Joseph McGuirk, MD | |
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Daniel Weisdorf, M.D. 612-624-0123 weisd001@umn.edu | |
| Principal Investigator: Daniel Weisdorf, MD | |
| Mayo Clinic Cancer Center | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mark Litzow, MD 507-284-2511 litzow.mark@mayo.edu | |
| Principal Investigator: Mark Litzow, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Peter Westervelt, MD 314-454-8323 pwesterv@im.wustl.edu | |
| Principal Investigator: Peter Westervelt, MD | |
| United States, New Jersey | |
| Hackensack University Medical Center | Not yet recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Alfred P. Gillio, MD 201-996-5437 agillio@humed.com | |
| Principal Investigator: Alfred P. Gillio, MD | |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Maureen Ross, MD 716-845-2300 maureen.ross@roswellpark.org | |
| Principal Investigator: Maureen Ross, MD | |
| New York Presbyterian Weill Cornell Medical Center | Recruiting |
| New York City, New York, United States, 10021 | |
| Contact: Tsiporah Shore, MD 212-746-2646 tbs2001@med.cornell.edu | |
| Principal Investigator: Tsiporah Shore, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Ronald Sobecks, MD 216-445-4626 sobeckr@ccf.org | |
| Principal Investigator: Ronald Sobecks, MD | |
| Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Steven M. Devine, MD 614-293-6794 steven.devine@osumc.edu | |
| Principal Investigator: Steven M. Devine, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: David Porter, MD 215-662-5858 david.porter@uphs.upenn.edu | |
| Principal Investigator: David Porter, MD | |
| United States, Texas | |
| Baylor Sammons Cancer Center | Not yet recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Edward Agura, MD edward.agura@baylorhealth.edu | |
| Principal Investigator: Edward Agura, MD | |
| M.D. Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Richard Champlin, MD rchampli@mdanderson.org | |
| Principal Investigator: Richard Champlin, MD | |
| Methodist Healthcare System of San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Paul Shaughnessy, MD 210-575-8500 paul.shaughnessy@MHShealth.com | |
| Principal Investigator: Paul Shaughnessy, MD | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Ann E Woolfrey, MD 206-667-4324 awoolfre@fhcrc.org | |
| Principal Investigator: Ann E Woolfrey, MD | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
| Principal Investigator: | Daniel Weisdorf, M.D. | Masonic Cancer Center, University of Minnesota |
More Information
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01288222 History of Changes |
| Other Study ID Numbers: | 2010LSUC043, MT2010-06, P01CA111412 |
| Study First Received: | February 1, 2011 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
acute myelogenous leukemia hematopoietic cell transplantation unrelated donor |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013