REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

  • STATUS
    Recruiting
  • End date
    May 15, 2026
  • participants needed
    50
  • sponsor
    University of Oklahoma
Updated on 15 May 2021

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. In this study we will use FLT imaging which is an investigational imaging test, and collect blood samples to investigate if the cells are growing well.

Description

This is a prospective pilot study whose primary aim is to determine whether investigational FLT imaging can detect and distinguish non-engraftment from delayed engraftment after hematopoietic stem cell transplantation (HSCT) in populations at highest risk for graft failure. The investigators will enroll 50 patients undergoing myeloblative transplantation on this trial (15 pediatric and adult recipients of cord blood stem cells, 15 pediatric and adult recipients of haplo-identical HSCT, and 20 recipients of these two stem cell sources who have not engrafted by day 28). The planned length of this trial is 5 years and it will be conducted at 3 centers: Emory/Children's Healthcare of Atlanta (pediatric and adult), University of Oklahoma (adult), and University of Michigan (pediatric and adult).

For all pediatric and adult patients undergoing cord blood HSCT, three FLT images will be taken: first, one day prior to HSCT and second and third, on days 9 and 28 after HSCT. For recipients of haplo-HSCT, the FLT images will be taken one day prior to HSCT and then on days 5 and 28 after HSCT. 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. Blood samples will also be collected from all patients for blood biomarker analysis, including thymidine kinase-1 (TK1). Each patient will be in this study for one year.

Details
Condition Primary Graft Failure
Treatment FLT imaging and TK1 blood measurements
Clinical Study IdentifierNCT03541889
SponsorUniversity of Oklahoma
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

General
Ability to undergo 18F FLT imaging without sedation
Able to perform FLT imaging without anesthesia
Patients > 4 years of age and less than 70 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
No investigational therapies within past 28 days Karnofsky or Lansky performance status > 60%
Arm A
Cord blood recipients: Absence of donor specific antibodies to cord HLA
Haplo-identical recipients: > 5/10 and < 7/8 allele mismatch donor
Diagnosed with a condition for which myeloablative 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)
Ejection fraction > 50% (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
Arm B
Inclusion Criteria - Donors
Non-engraftment recipients of cord or > 5/10 and < 7/8 allele mismatch donor
transplant (related or unrelated): primary graft failure as defined by ANC not
> 500 for 3 consecutive days and at least 24 days after HSCT
Institutional guidelines met for donor suitability
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

Exclusion Criteria

History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Presence of active malignancy from an organ system other than hematopoietic
Pregnant or lactating females
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
Prior history of fluorothymidine allergy or intolerance
Patients who are unable or unwilling to use effective form (s) of contraception during the course of the study
Decline enrolment on CIBMTR research protocol
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note