RECRUITING

REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

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Conditions

Primary Graft Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multi-institutional Prospective Pilot Research of Imaging and Blood Biomarker EValuation of Engraftment After ALlogeneic Hematopoietic Stem Cell Transplantation

Quick Facts

Study Start:2021-02-05
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03541889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to undergo 18F FLT imaging without sedation
  2. * 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.
  3. * 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)
  4. * In morphologic remission prior to HSCT
  5. * Patient or guardian able to give informed consent
  6. * Investigational therapies within past 28 days or planned on protocol are pre-approved by the PI or Site PI
  7. * Karnofsky or Lansky performance status \> 60%
  8. * A1 Cord blood recipients: Absence of donor specific antibodies to cord HLA
  9. * Haplo-identical recipients: ≥ 5/10 and \< 7/8 allele mismatch donor
  10. * A2- myeloablative Haplo-identical transplant is planned
  11. * A3- reduced intensity Haplo-identical transplant is planned (non-myeloablative is excluded)
  12. * A1- myeloablative or reduced intensity transplant is planned (non-myeloablative is excluded)
  13. * Diagnosed with a condition for which hematopoietic stem cell transplant (HSCT) is standard of care and HSCT is planned
  14. * Total bilirubin \< 2.5 mg/dL (unless documented Gilbert's syndrome) and transaminases (ALT and AST) \< 5 x the upper limit of normal
  15. * Creatinine clearance or GFR \> 60 ml/min/1.73 m2. (performed pre-HSCT)
  16. * 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
  17. * Ejection fraction \> 50% (performed pre-HSCT)
  18. * 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
  19. * Institutional guidelines met for donor suitability
  1. * History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
  2. * 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
  3. * Presence of active malignancy from an organ system other than hematopoietic
  4. * Pregnant or lactating females
  5. * Patients who are unable or unwilling to use effective form (s) of contraception during the course of the study
  6. * Prior history of fluorothymidine allergy or intolerance
  7. * Decline enrolment on CIBMTR research protocol

Contacts and Locations

Study Contact

Kirsten M Williams, MD
CONTACT
404-727-4253
kirsten.marie.williams@emory.edu
Jennifer Holter, MD
CONTACT
Jennifer-Holter@ouhsc.edu

Principal Investigator

Kirsten Williams, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University Hospital of Cleveland UH Seidman Cancer Center
Cleveland, Ohio, 44106
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Kirsten Williams, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-05
Study Completion Date2026-05

Study Record Updates

Study Start Date2021-02-05
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Primary Graft Failure