REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

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.

Conditions

Primary Graft Failure

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

Condition
Primary Graft Failure
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Cleveland

University Hospital of Cleveland UH Seidman Cancer Center, Cleveland, Ohio, United States, 44106

Oklahoma City

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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%
  • * 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
  • * 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)
  • * 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
  • * Institutional guidelines met for donor suitability
  • * 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

Ages Eligible for Study

4 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Kirsten Williams, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2026-05