Actively Recruiting
REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
Led by University of Oklahoma · Updated on 2026-03-05
56
Participants Needed
4
Research Sites
351 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to undergo 18F FLT imaging without sedation
- Age between 4 and less than 80 years
- At high risk for graft failure: cord blood HSCT, haplo-identical HSCT, or lack of engraftment by day 28
- Diagnosed with a condition for which HSCT is standard care and HSCT is planned or has occurred
- In morphologic remission prior to HSCT
- Patient or guardian able to give informed consent
- Investigational therapies within past 28 days or planned are pre-approved by the study investigator
- Karnofsky or Lansky performance status greater than 60%
- For cord blood recipients: absence of donor specific antibodies to cord HLA
- For haplo-identical recipients: 5/10 or greater and less than 7/8 allele mismatch donor
- Planned myeloablative or reduced intensity haplo-identical transplant (non-myeloablative excluded)
- Total bilirubin less than 2.5 mg/dL (unless Gilbert's syndrome) and liver enzymes less than 5 times upper limit normal
- Creatinine clearance or GFR greater than 60 ml/min/1.73 m2
- Lung function: FEV1 greater than 80% and DLCO adjusted greater than 70%, SaO2 greater than 94% on room air
- Ejection fraction greater than 50%
- For non-engraftment recipients: primary graft failure defined by ANC not greater than 500 for 3 days at least 20 days after HSCT
- Donors meet institutional suitability guidelines with 1-2 cords and at least 0.4/6 match or related donor with 5/10 and less than 7/8 allele mismatch
You will not qualify if you...
- History of psychiatric disorder that compromises compliance or informed consent
- Significant systemic illness causing organ dysfunction making protocol therapy unlikely to be tolerated
- Active malignancy outside hematopoietic system
- Pregnant or lactating females
- Unable or unwilling to use effective contraception during study
- Prior allergy or intolerance to fluorothymidine
- Declined enrollment on CIBMTR research protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
University Hospital of Cleveland UH Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
4
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
K
Kirsten M Williams, MD
CONTACT
J
Jennifer Holter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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