Identifying Biomarkers for Bone Marrow Cell Growth After Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate whether FLT imaging can effectively detect and differentiate between nonengraftment and delayed engraftment in patients undergoing hematopoietic stem cell transplantation (HSCT). The study will enroll up to 56 patients at high risk for graft failure, including those receiving cord blood or haplo-identical HSCT. Participants will undergo FLT imaging before and after the transplant, along with blood sample collection to assess cell growth. The trial is expected to last for 7 years and will take place across four medical centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Inclusion Criteria - Donors

* 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

Exclusion Criteria:

* 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

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• University of Oklahoma Health Sciences Center, Stephenson Cancer Center
  Oklahoma City, Oklahoma, United States Recruiting
• University Hospital of Cleveland UH Seidman Cancer Center
  Cleveland, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Kirsten Williams, MD — Emory University
• Study coordinator: Kirsten M Williams, MD
• Email: kirsten.marie.williams@emory.edu
• Phone: 404-727-4253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.