Clinical trialNCT01385787CompletedObservational

MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia

SponsorCenter for International Blood and Marrow Transplant ResearchEnrollment150Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral blood and bone marrow: 1) pre-HCT (\<3 weeks prior to starting the preparative regimen), 2) day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT. For two years after transplant, the subject's follow-up data will be collected using the Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective is to determine whether there is any association between level of pre-transplant and post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival, and to estimate the strength of that association in terms of the predictive accuracy of MRD. The investigators hypothesize that measurable MRD at either time point will be associated with decreased 2-year event-free survival.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David A. Jacobsohn, MD, ScM
Children's National Research Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

38 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
Children'S & Women'S Health Centre of British Columbia
Vancouver, British Columbia, Canada
Hopital Ste. Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital
Montreal, Quebec, Canada

United States

the Children'S Hospital of Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Loma Linda University
Loma Linda, California, United States
University of California San Francisco
San Francisco, California, United States
the Children'S Hospital Colorado
Aurora, Colorado, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Miami Children'S Hospital
Miami, Florida, United States
All Children'S Hospital
St. Petersburg, Florida, United States
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
Lurie Children'S Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children/indiana University
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Children'S Hospital of Michigan
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University, St. Louis Children'S Hospital
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University - the Morgan Stanley Children'S Hospital of New York
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
New York Medical College
Valhalla, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals of Cleveland Case Medical Ctr
Cleveland, Ohio, United States
Oregon Health & Sciences University - Doerbecher Children'S
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Children'S Hospital of South Texas/texas Institute of Medicine and Surgery
San Antonio, Texas, United States
University of Utah - Primary Children'S Medical Center
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Children'S Hospital of Wisconsin
Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2011
Primary completion: 31 May 2017
Completion: 31 May 2017
Last update posted: 7 Sept 2017
Registered enrollment: 150
Registry id: NCT01385787

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.