Primary Graft Failure Clinical Trial
Official title:
Multi-institutional Prospective Pilot Research of Imaging and Blood Biomarker EValuation of Engraftment After ALlogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to find new tests that could help determine if the newly infused bone marrow cells are growing well after bone marrow transplantation or if new bone marrow cells are needed. In this study we will use FLT imaging which is an investigational imaging test, and collect blood samples to investigate if the cells are growing well.
This is a prospective pilot study whose primary aim is to determine whether investigational FLT imaging can detect and distinguish non-engraftment from delayed engraftment after hematopoietic stem cell transplantation (HSCT) in populations at highest risk for graft failure. The investigators will enroll 50 patients undergoing myeloblative transplantation on this trial (15 pediatric and adult recipients of cord blood stem cells, 15 pediatric and adult recipients of haplo-identical HSCT, and 20 recipients of these two stem cell sources who have not engrafted by day 28). Should a patient be unable to undergo FLT evaluation after enrollment or relapse in the first 30 days, the patient will be replaced. The planned length of this trial is 5 years and it will be conducted at 3 centers enrolling pediatric and adult participants: Emory/Children's Healthcare of Atlanta, University of Oklahoma, and University of Michigan. For all pediatric and adult patients undergoing cord blood HSCT, three FLT images will be taken: first, one day prior to HSCT and second and third, on days 9 and 28 after HSCT. For recipients of haplo-HSCT, the FLT images will be taken one day prior to HSCT and then on days 5 and 28 after HSCT. Pediatric and adult patients who have not engrafted by day 24 after cord or haplo-identical HSCT will undergo a single FLT PET/CT image within one week, to determine if this scan can identify graft failure versus delayed engraftment. Blood samples will also be collected from all patients for blood biomarker analysis, including thymidine kinase-1 (TK1). Each patient will be in this study for one year. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02161783 -
Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
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| Enrolling by invitation |
NCT04105803 -
Cardiac Mitochondrial Function After Heart Transplantation
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