NCT03541889 REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
| NCT ID | NCT03541889 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Oklahoma |
| Condition | Primary Graft Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-10-21 |
| Primary Completion | 2026-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2020-10-21 with a primary completion date of 2026-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Kirsten Williams, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT03541889 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 80 Years, studying Primary Graft Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03541889 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03541889 currently recruiting?
Yes, NCT03541889 is actively recruiting participants. Contact the research team at kirsten.marie.williams@emory.edu for enrollment information.
Where is the NCT03541889 trial being conducted?
This trial is being conducted at Atlanta, United States, Ann Arbor, United States, Cleveland, United States, Oklahoma City, United States.
Who is sponsoring the NCT03541889 clinical trial?
NCT03541889 is sponsored by University of Oklahoma. The principal investigator is Kirsten Williams, MD at Emory University. The trial plans to enroll 50 participants.