REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

• Status: Recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborators: Children's National Health System; Emory University; University of Michigan

Criteria

Inclusion Criteria:

General

• 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.

• 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)

• Able to perform FLT imaging without anesthesia

• In morphologic remission prior to HSCT

• Patient or guardian able to give informed consent

• No investigational therapies within past 28 days Karnofsky or Lansky performance status > 60%

Arm A

• 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)

• 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 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.

Inclusion Criteria - Donors

• 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