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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT01385787

Public ClinicalTrials.gov record NCT01385787. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 6:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Role of Minimal Residual Disease Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01385787
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
150 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
Up to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2011 (Actual)
Primary completion
May 2017 (Actual)
Completion
May 2017 (Actual)
Last update posted
Sep 7, 2017

2011 – 2017

United States locations

U.S. sites
34
U.S. states
26
U.S. cities
32
Facility City State ZIP Site status
The Children's Hospital of Alabama, University of Alabama at Birmingham Birmingham Alabama 35233 —
Phoenix Children's Hospital Phoenix Arizona 85016 —
Loma Linda University Loma Linda California 92354 —
University of California San Francisco San Francisco California 94143 —
The Children's Hospital Colorado Aurora Colorado 80045 —
Children's National Medical Center Washington D.C. District of Columbia 20910 —
Miami Children's Hospital Miami Florida 33155 —
All Children's Hospital St. Petersburg Florida 33701 —
Children's Healthcare of Atlanta Atlanta Georgia 30322 —
Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Riley Hospital for Children/Indiana University Indianapolis Indiana 46202 —
University of Louisville Louisville Kentucky 40202 —
Johns Hopkins Baltimore Maryland 21287 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
University of Michigan Ann Arbor Michigan 48109 —
Children's Hospital of Michigan Detroit Michigan 48201 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Washington University, St. Louis Children's Hospital St Louis Missouri 63110 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Roswell Park Cancer Institute Buffalo New York 14263 —
Mount Sinai School of Medicine New York New York 10029 —
Columbia University - The Morgan Stanley Children's Hospital of New York New York New York 10032 —
New York Medical College Valhalla New York 10595 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Duke University Medical Center Durham North Carolina 27705 —
University Hospitals of Cleveland Case Medical Ctr Cleveland Ohio 44106 —
Cleveland Clinic Cleveland Ohio 44195 —
Oregon Health & Sciences University - Doerbecher Children's Portland Oregon 97239 —
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Medical University of South Carolina Charleston South Carolina 29425 —
Methodist Children's Hospital of South Texas/Texas Institute of Medicine and Surgery San Antonio Texas 78229 —
University of Utah - Primary Children's Medical Center Salt Lake City Utah 84108 —
Virginia Commonwealth University Richmond Virginia 23219 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01385787, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2017 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01385787 live on ClinicalTrials.gov.

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