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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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

• 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)

⁃ Arm B

⁃ • Non-engraftment recipients of HCT with any donor source (related or unrelated): primary graft failure as defined by ANC not \> 500 for 3 consecutive days and at least 20 days after 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

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Michigan
University of Michigan
RECRUITING
Ann Arbor
Ohio
University Hospital of Cleveland UH Seidman Cancer Center
NOT_YET_RECRUITING
Cleveland
Oklahoma
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
RECRUITING
Oklahoma City
Contact Information
Primary
Kirsten M Williams, MD
kirsten.marie.williams@emory.edu
404-727-4253
Backup
Jennifer Holter, MD
Jennifer-Holter@ouhsc.edu
Time Frame
Start Date: 2021-02-05
Estimated Completion Date: 2027-11
Participants
Target number of participants: 56
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, University of Michigan, National Heart, Lung, and Blood Institute (NHLBI), University Hospitals Cleveland Medical Center
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov

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