REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

  • End date
    May 24, 2026
  • participants needed
  • sponsor
    University of Oklahoma
Updated on 24 May 2022


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). The planned length of this trial is 5 years and it will be conducted at 3 centers: Emory/Children's Healthcare of Atlanta (pediatric and adult), University of Oklahoma (adult), and University of Michigan (pediatric and adult).

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.

Condition Primary Graft Failure
Treatment FLT imaging and TK1 blood measurements
Clinical Study IdentifierNCT03541889
SponsorUniversity of Oklahoma
Last Modified on24 May 2022


Yes No Not Sure

Inclusion Criteria

Ability to undergo 18F FLT imaging without sedation
Patients > 4 years of age and less than 70 years of age at highest risk for graft failure: cord blood HSCT, haplo HSCT, or lack of engraftment by day 28
Able to perform FLT imaging without anesthesia
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
Patient or guardian able to give informed consent
Arm A
No investigational therapies within past 28 days Karnofsky or Lansky performance status > 60%
Cord blood recipients: Absence of donor specific antibodies to cord HLA
Haplo-identical recipients: ≥ 5/10 and < 7/8 allele mismatch donor
Diagnosed with a condition for which myeloablative hematopoietic stem cell transplant (HSCT) is standard of care and HSCT is planned
Total bilirubin < 2.5 mg/dL (unless documented Gilbert's syndrome) and transaminases (ALT and AST) < 5 x the upper limit of normal
Creatinine clearance or GFR > 60 ml/min/1.73 m2. (performed pre-HSCT)
Ejection fraction > 50% (performed pre-HSCT)
Arm B
FEV1 > 80% pre or post-bronchiolator whichever is higher and DLCO Adj > 70% (performed pre-HSCT if age appropriate) and Sa02 > 94% on room air
Inclusion Criteria - Donors
• Non-engraftment recipients of cord or > 5/10 and < 7/8 allele mismatch donor transplant
(related or unrelated): primary graft failure as defined by ANC not > 500 for 3 consecutive
days and at least 24 days after HSCT
Institutional guidelines met for donor suitability
cords and >.4/6 match to recipient for each (as per current National Marrow Donor
guidelines), with a dose >2 x 10e6 CD34 cells/kg for each cord OR > 5/10 and <7/8
allele mismatch related donor

Exclusion Criteria

Presence of active malignancy from an organ system other than hematopoietic
Pregnant or lactating females
History of psychiatric disorder which may compromise compliance with transplant
Prior history of fluorothymidine allergy or intolerance
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
Decline enrolment on CIBMTR research protocol
unlikely to tolerate the protocol therapy or complete the study
Patients who are unable or unwilling to use effective form (s) of contraception during
the course of the study
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