New tests aim to spot bone marrow graft failure early
NCT ID NCT03541889
First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times
Summary
This study is testing two new ways to check if donated bone marrow cells are growing well after a transplant. Researchers will use a special PET scan (FLT imaging) and blood tests (TK1 levels) in about 56 people who are at high risk for graft failure. The goal is to find better tools to detect problems early, so doctors can act quickly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FLT imaging and TK1 blood measurements
- What this could lead to
- If successful, these tests could help doctors quickly tell if a bone marrow transplant is working, allowing earlier treatment for graft failure.
- What could go wrong
- This is a small, early-phase pilot study (56 people) testing new methods, so results may not apply broadly or lead to a proven test.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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University Hospital of Cleveland UH Seidman Cancer Center
NOT_YET_RECRUITINGCleveland, Ohio, 44106, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Oklahoma Health Sciences Center, Stephenson Cancer Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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