Selecting a Favorable KIR Donor in Unrelated HCT for AML

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01288222
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 506
• Locations: 19
• Arm: 1
• Actual Duration (Months): 106
• Patients Per Site: 26.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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:

1. Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML.

2. 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 or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia	Other: KIR genotype	N/A

Detailed Description

Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 506 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unrelated Donor Transplant Patients Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant.	Other: KIR genotype; KIR genotype data from unrelated donor are collected

Outcome Measures

Primary Outcome Measures

1. Incidence of Relapse [2 Years]

   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

1. Incidence of Relapse-Free Survival [2 Years]

2. Overall Survival [2 Years]

3. Incidence of Engraftment [2 Years]

4. Incidence of Graft Versus Host Disease [2 Years]

5. Incidence of Transplant Related Mortality [2 Years]

   Number of patients who died within 2 years of transplant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Exclusion Criteria:

Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor. In situations where the preferred (best > better > neutral) KIR donor is not selected in favor of a less favorable KIR genotype donor, the center will report one or more defined reasons (donor age; gender; parity; CMV status; ABO status; availability/logistics; other) for the choice (among equivalently HLA matched donors).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic - Scottsdale	Scottsdale	Arizona	United States	85259
2	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
3	Emory University	Atlanta	Georgia	United States	30322
4	University of Chicago Medical Center Cancer Center	Chicago	Illinois	United States	60637
5	Indiana University Simon Cancer Center	Indianapolis	Indiana	United States	46202
6	Kansas University Cancer Center	Kansas City	Kansas	United States	66160
7	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455
8	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
9	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
10	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
11	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
12	New York Presbyterian Weill Cornell Medical Center	New York	New York	United States	10021
13	Cleveland Clinic	Cleveland	Ohio	United States	44195
14	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
15	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
16	Baylor Sammons Cancer Center	Dallas	Texas	United States	75246
17	M.D. Anderson Cancer Center	Houston	Texas	United States	77030
18	Methodist Healthcare System of San Antonio	San Antonio	Texas	United States	78229
19	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Daniel Weisdorf, M.D., Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT01288222
• Other Study ID Numbers: 2010LSUC043; MT2010-06; P01CA111412
• First Posted: Feb 2, 2011
• Last Update Posted: Mar 11, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Masonic Cancer Center, University of Minnesota: acute myelogenous leukemia; hematopoietic cell transplantation; unrelated donor
• Additional relevant MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Mar 11, 2021