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NCT01288222 · ClinicalTrials.gov registry record · NA
Selecting a Favorable KIR Donor in Unrelated HCT for AML
A NA study of Acute Myelogenous Leukemia, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 506
- Enrollment target
- 19
- Study locations
NCT01288222: Completed NA study of Acute Myelogenous Leukemia, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01288222 is a NA study of Acute Myelogenous Leukemia that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 506 participants, above the 127-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (298% higher). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01288222, a NA study of Acute Myelogenous Leukemia, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 506 participants
- Enrollment target
- 19
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER KIR genotype
Study Locations (19)
Texas
- Baylor Sammons Cancer Center - Dallas
- M.D. Anderson Cancer Center - Houston
- Methodist Healthcare System of San Antonio - San Antonio
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
- Mayo Clinic Cancer Center - Rochester
New York
- Roswell Park Cancer Institute - Buffalo
- New York Presbyterian Weill Cornell Medical Center - New York
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
Arizona
- Mayo Clinic - Scottsdale - Scottsdale
Colorado
- Colorado Blood Cancer Institute - Denver
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago Medical Center Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2011-06 |
| Est. Completion | 2020-04 |
| Phase | NA |
What the finished NCT01288222 record still lists
NCT01288222 is an interventional study that assigns participants to a tested intervention. The registered 506 participants enrollment target is mid-sized for trials with a published cap, above the 127-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (298% higher).
The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which KIR genotype is the first listed.
NCT01288222 lists 19 locations in 14 states (Texas, Minnesota, New York).
Frequently Asked Questions
What is clinical trial NCT01288222 about?
NCT01288222 is a clinical study titled "Selecting a Favorable KIR Donor in Unrelated HCT for AML". 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 c...
What is the current status of trial NCT01288222?
This trial is currently completed. It is a NA study. The enrollment target is 506 participants. The study started on 2011-06. Estimated completion is 2020-04.
What conditions does trial NCT01288222 study?
This clinical trial studies the following conditions: Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT01288222?
The interventions under investigation include: KIR genotype (OTHER).
Who is sponsoring clinical trial NCT01288222?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01288222 being conducted?
This trial has 19 study locations across Arizona, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01288222's enrollment target sits among peer trials
506 2nd of 38 the highest of 38 other Acute Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myelogenous Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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