REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
ConditionPrimary Graft Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-80
SponsorUniversity of Oklahoma
About this trial
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. The Investigator will use FLT imaging, an investigational imaging test, and collect blood samples to investigate whether the cells are growing well.
Eligibility criteria
Qualifiers
Ability to undergo 18F FLT imaging without sedation
Patients > 4 years of age and less than 80 years of age at highest risk for graft failure: cord blood HSCT, haplo HSCT, or lack of engraftment by day 28.
Diagnosed with a condition for which hematopoietic stem cell transplant (HSCT) is standard of care and HSCT is planned (Arm A) or occurred (Arm B)
In morphologic remission prior to HSCT
Disqualifiers
History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Clinically significant systemic illness with manifestations of significant organ dysfunction which, in the judgment of the PI, or Co-I, would render the patient unlikely to tolerate the protocol therapy or complete the study
Presence of active malignancy from an organ system other than hematopoietic
Pregnant or lactating females
Trial design
Treatments tested in this trial
- FLT imaging and TK1 blood measurements
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oklahoma
Lead sponsor
Emory University
Collaborator
University of Michigan
Collaborator
University Hospitals Cleveland Medical Center
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov