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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: Completed study, sponsored by Center for International Blood and Marrow Transplant Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Event-free survival is defined as the time from HCT to relapse, death, initiation of post-HCT therapy to treat AML relapse, loss to follow up or end of study whichever comes first.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-05 |
What the finished NCT01385787 record still lists
NCT01385787 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01385787 does not publish any study locations in the registry export this page uses.
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.
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