NCT03541889 · University of Oklahoma
REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
(REVEAL)
What this study 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 experimental imaging test, and collect blood samples to investigate whether the cells are growing well.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Atlanta, Georgia
- Ann Arbor, Michigan
- Cleveland, Ohio
- Oklahoma City, Oklahoma
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations