Acute Myelogenous LeukemiaNCT01288222
Selecting a Favorable KIR Donor in Unrelated HCT for AML
A study testing KIR genotype in people with Acute Myelogenous Leukemia, run by Masonic Cancer Center, University of Minnesota at 19 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- KIR genotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 19 sitesUnited States
- Study dates
- Jun 2011to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory University
Atlanta, Georgia, 30322
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Chicago Medical Center Cancer Center
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Baylor Sammons Cancer Center
Dallas, Texas, 75246
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Hackensack University Medical Center
Hackensack, New Jersey, 07601
M.D. Anderson Cancer Center
Houston, Texas, 77030
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Kansas University Cancer Center
Kansas City, Kansas, 66160
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
New York Presbyterian Weill Cornell Medical Center
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor
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.
Read the detailed description
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- KIR genotype
- Keywords
- acute myelogenous leukemia, hematopoietic cell transplantation, unrelated donor
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIR genotypeOther
KIR genotype data from unrelated donor are collected
| Study group | Role | What they receive |
|---|---|---|
| Unrelated Donor Transplant Patients | Experimental | Patients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant. Receives: Other: KIR genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Relapse
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.
Measured: 2 Years
Secondary outcomes (5)
Incidence of Relapse-Free Survival
Measured: 2 Years
Overall Survival
Measured: 2 Years
Incidence of Engraftment
Measured: 2 Years
Incidence of Graft Versus Host Disease
Measured: 2 Years
Incidence of Transplant Related Mortality
Number of patients who died within 2 years of transplant.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel Weisdorf, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288222
- Sponsor's protocol ID
- 2010LSUC043
- Other IDs
- MT2010-06, P01CA111412
- Status last verified
- Mar 2021
- First submitted
- 1 Feb 2011
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cooley S, Weisdorf DJ, Guethlein LA, Klein JP, Wang T, Marsh SG, Spellman S, Haagenson MD, Saeturn K, Ladner M, Trachtenberg E, Parham P, Miller JS. Donor killer cell Ig-like receptor B haplotypes, recipient HLA-C1, and HLA-C mismatch enhance the clinical benefit of unrelated transplantation for acute myelogenous leukemia. J Immunol. 2014 May 15;192(10):4592-600. doi: 10.4049/jimmunol.1302517. Epub 2014 Apr 18.
PubMed 24748496
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor
- ClinicalTrials.gov ID
- NCT01288222
- Acronym / sponsor ID
- 2010LSUC043
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- acute myelogenous leukemia, hematopoietic cell transplantation, unrelated donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2011 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unrelated Donor Transplant Patients | Experimental | Other: KIR genotypePatients with acute myeloid leukemia who have received KIR genotype from an unrelated donor transplant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIR genotypeKIR genotype data from unrelated donor are collected | Other | Unrelated Donor Transplant Patients |
Primary outcome
Incidence of Relapse
Time frame: 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.
5 secondary outcomes
Incidence of Relapse-Free Survival
Time frame: 2 Years
Overall Survival
Time frame: 2 Years
Incidence of Engraftment
Time frame: 2 Years
Incidence of Graft Versus Host Disease
Time frame: 2 Years
Incidence of Transplant Related Mortality
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 24748496Cooley S, Weisdorf DJ, Guethlein LA, Klein JP, Wang T, Marsh SG, Spellman S, Haagenson MD, Saeturn K, Ladner M, Trachtenberg E, Parham P, Miller JS. Donor killer cell Ig-like receptor B haplotypes, recipient HLA-C1, and HLA-C mismatch enhance the clinical benefit of unrelated transplantation for acute myelogenous leukemia. J Immunol. 2014 May 15;192(10):4592-600. doi: 10.4049/jimmunol.1302517. Epub 2014 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weisdorf, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIR genotype in people with Acute Myelogenous Leukemia, run by Masonic Cancer Center, University of Minnesota at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Relapse (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.