REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Oklahoma
Study ID
NCT03541889
Phase
PHASE1
Status
Recruiting
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Conditions

  • Primary Graft Failure

Eligibility Criteria

Sex
ALL
Age
4 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • FLT imaging and TK1 blood measurements — DRUG
    F18 labeled thymidine PET/CT scans will be performed. Serum measurements of TK1 will be obtained.

Study Details

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.

Key Dates

Start date
Feb 5, 2021
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cord and haplo imaging cohort
    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.
  • Experimental: Nonengrafted cohort
    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.

Primary Outcome Measure

FLT SUV identifies graft failure [ Time Frame: 24-28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Kirsten M Williams, MD
[email protected]
Kirsten M Williams, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Gregory A Yanick, MD
Gregory A Yanick, MD (PRINCIPAL_INVESTIGATOR)
University Hospital of Cleveland UH Seidman Cancer CenterClevelandOhio44106
Leland Metheny, MD
[email protected]
Leland Metheny, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences Center, Stephenson Cancer CenterOklahoma CityOklahoma73104
Jennifer Holter, MD
[email protected]
405-271-8777
IIT Office
[email protected]
Jennifer Holter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MIUniversity Hospital of Cleveland UH Seidman Cancer Center· Cleveland, OHUniversity of Oklahoma Health Sciences Center, Stephenson Cancer Center· Oklahoma City, OK

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