Recruiting

Phase 1

Engraftment BiomarkersREVEAL Biomarkers of Engraftment After Alternative Donor HSCT

Sponsor:

University of Oklahoma

Code:

NCT03541889

Conditions

Primary Graft Failure

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

Interventions

FLT imaging and TK1 blood measurements

Study Details

Brief summary:

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

Primary Graft Failure

Study ID

NCT03541889

Start date

Oct 21, 2020

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Dec 14, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

General

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
Patient or guardian able to give informed consent
Investigational therapies within past 28 days or planned on protocol are pre-approved by the PI or Site PI
Karnofsky or Lansky performance status > 60%

Arm A

A1 Cord blood recipients: Absence of donor specific antibodies to cord HLA
Haplo-identical recipients: ≥ 5/10 and < 7/8 allele mismatch donor
A2- myeloablative Haplo-identical transplant is planned
A3- reduced intensity Haplo-identical transplant is planned (non-myeloablative is excluded)
A1- myeloablative or reduced intensity transplant is planned (non-myeloablative is excluded)
Diagnosed with a condition for which 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)
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
Ejection fraction > 50% (performed pre-HSCT)

Arm B

• Non-engraftment recipients of HCT with any donor source (related or unrelated): primary graft failure as defined by ANC not > 500 for 3 consecutive days and at least 20 days after HSCT.

Inclusion Criteria - Donors

1-2 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
Institutional guidelines met for donor suitability

Exclusion Criteria:

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
Patients who are unable or unwilling to use effective form (s) of contraception during the course of the study
Prior history of fluorothymidine allergy or intolerance
Decline enrolment on CIBMTR research protocol

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cord and haplo imaging cohort

For all pediatric and adult patients undergoing cord blood HSCT, FLT PET/CT imaging will occur one day prior to HSCT and on days 9 and 28 after HSCT. For recipients of haplo-HSCT, FLT PET/CT imaging will occur one day prior to HSCT and on days 5 and 28 after HSCT.

experimental: Nonengrafted cohort

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.

Interventions

FLT imaging and TK1 blood measurements

F18 labeled thymidine PET/CT scans will be performed. Serum measurements of TK1 will be obtained.

Primary outcome measure

FLT SUV identifies graft failure [ Time Frame: 24-28 days ]

Central Contacts and Locations

Central contacts

Kirsten M Williams, MD

404-727-4253 kirsten.marie.williams@emory.edu

Jennifer Holter, MD

Jennifer-Holter@ouhsc.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kirsten M Williams, MD

kirsten.marie.williams@emory.edu

Principal Investigator:

Kirsten M Williams, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Gregory A Yanick, MD

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Jennifer Holter, MD

405-271-8777 Jennifer-Holter@ouhsc.edu

IIT Office

SCC-IIT-Office@ouhsc.edu

Principal Investigator:

Jennifer Holter, MD

More Information

Sponsor

University of Oklahoma

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-08-18.