REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

NCT03541889 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OU-SCC-REVEAL5R01HL146668-04
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• FLT SUV identifies graft failure

  To calculate if SUV \> 1.2 identifies subclinical engraftment using FLT PET/CT imaging for recipients of cord and haplo-HSCT who have not engrafted within 24 days of HSCT.

  24-28 days

Secondary Outcomes (4)

• Map subclinical engraftment in alternative donor HSCT

  Day -1 to Day 28 after HSCT

• TK1 serum levels identify graft failure

  24-28 days

• Number of patients with CTCAE version 5 events exceeding grade 3 that are possibly, probably, or definitely attributed to the FLT imaging

  Day -1 to Day 28 after HSCT

• Other cytokine and chemokine markers of graft failure

  24-28 days

Study Arms (2)

Cord and haplo imaging cohort

EXPERIMENTAL

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.

Drug: FLT imaging and TK1 blood measurements

Nonengrafted cohort

EXPERIMENTAL

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.

Drug: FLT imaging and TK1 blood measurements

Interventions

FLT imaging and TK1 blood measurements DRUG

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

Cord and haplo imaging cohort; Nonengrafted cohort

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Emory University: collaborator
• University of Michigan: collaborator
• University Hospitals Cleveland Medical Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

University Hospital of Cleveland UH Seidman Cancer Center

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Study Officials

• Kirsten Williams, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten M Williams, MD

CONTACT

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

Jennifer Holter, MD

CONTACT

Jennifer-Holter@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 31, 2018
• Study Start: February 5, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)