Health TrialsbyHealthPanel

REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

ConditionPrimary Graft Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-80
SponsorUniversity of Oklahoma

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FLT imaging and TK1 blood measurements

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Cord and haplo imaging cohortExperimental treatment 1 intervention
Group B: Nonengrafted cohortExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24-28 days

Secondary outcomes

1

Map subclinical engraftment in alternative donor HSCT

Use SUV increase in particular medullary spaces to identify the first site of marrow settling after HSCT in alternative donor HSCT

Time frame
Day -1 to Day 28 after HSCT
2

TK1 serum levels identify graft failure

Calculate if TK1 level increases correlate with clinical engraftment

Time frame
24-28 days
3

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

Safety of FLT in alternative donor HSCT - Calculate the number of patients with CTCAE version 5 events exceeding grade 3 that are possibly, probably, or definitely attributed to the FLT imaging

Time frame
Day -1 to Day 28 after HSCT
4

Other cytokine and chemokine markers of graft failure

Explore other cellular, cytokine, and chemokine markers of subclinical engraftment

Time frame
24-28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Emory University

Collaborator

University of Michigan

Collaborator

University Hospitals Cleveland Medical Center

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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