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NCT01385787 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Center for International Blood and Marrow Transplant Research.

Completed
Registry status
150
Enrollment target

NCT01385787 is a clinical trial that has completed, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 150 participants.

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The verdict

NCT01385787 has completed, sponsored by Center for International Blood and Marrow Transplant Research.

COMPLETED
Registry status
150 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2011-10
Est. Completion 2017-05

What the Registry Record Tells You About NCT01385787

The ClinicalTrials.gov registry entry for NCT01385787 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for International Blood and Marrow Transplant Research, which has 29 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01385787 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01385787 about?

NCT01385787 is a clinical study titled "MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia". 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...

What is the current status of trial NCT01385787?

This trial is currently completed. The enrollment target is 150 participants. The study started on 2011-10. Estimated completion is 2017-05.

Who is sponsoring clinical trial NCT01385787?

This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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