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New treatment option for Primary Graft Failure
Official title REVEAL Biomarkers of Engraftment After Alternative Donor HSCT
ClinicalTrials.gov ID: NCT03541889
What this study is testing
What is FLT imaging and TK1 blood measurements?
FLT imaging and TK1 blood measurements is an investigational medicine, being studied as a potential treatment for primary graft failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Ann Arbor, Michigan, United States; Cleveland, Ohio, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.