18-FLT PET/MR Imaging to Predict Graft Failure and GVHD in Bone Marrow Transplant Patients

Stopped early · Early Phase 1

Conditions studied: Graft Vs Host Disease

In brief

Allogeneic HSCT is potentially curative for numerous high risk hematologic malignancies and offers several advantages over traditional chemotherapy. First, higher doses of cytotoxic chemotherapy and/or irradiation can be given since patients are subsequently rescued from the severe myelosuppression induced by the pre-transplant conditioning regimen by the infusion of healthy hematopoietic stem cells. Second and perhaps more importantly, mature T cells contained in the graft are able to mount immune responses against residual cancer cells surviving the conditioning regimen due to major and/or minor MHC disparities between the donor and recipient. Unfortunately, the allo-immune responses driving the GVL effect are typically not specific for malignant cells. As a consequence, donor immune cells attack normal host tissues resulting in a process known as acute graft-versus-host disease (GVHD). Acute GVHD is primarily T cell driven, usually occurs within the first few months after transplant, and results in skin rash, diarrhea, cholestatic liver damage, and, on occasion, acute lung injury.

Key facts

Study ID

NCT03546556

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

10

Starts

2017-01-01

Expected to finish

2020-03-12

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing allogeneic bone marrow transplant for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome
• Allogeneic transplant patients receiving either a fully myeloablative or reduced intensity chemotherapy +/- total body irradiation (TBI) conditioning regimen are eligible.
• Allogeneic transplant patients receiving stem cells from a matched related, matched unrelated, mismatched unrelated, mismatched related (including haplotype matched) donors are eligible
• Allogeneic transplant patients must be in a complete morphologic remission prior to transplant
• Patients undergoing autologous bone marrow transplant for multiple myeloma
• Myeloma patients must have achieved at least a very good partial remission prior to transplant and exhibit fewer than 10% plasma cells in their pre-transplant marrow biopsy
• At least 18 years of age
• Negative urine pregnancy test in women of child-bearing potential

You may not qualify if…

• Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating.
• Condition that makes MRI unsafe (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, metal halo devices)
• Inability to tolerate MRI (e.g., unable to lie flat for > 1 hour, severe claustrophobia)
• Known allergy to fluorothymidine
• Creatinine clearance < 40 ml/min, as estimated by the Cockcroft-Gault formula
• Body Mass Index (BMI) > 35
• Poorly controlled diabetes mellitus (fasting blood glucose > 500 mg/dl)
• Institutionalized subject (prisoner or nursing home patient)
• Critically ill or medically unstable
• Currently hospitalized (All FLT PET/MR scans will be obtained in the outpatient setting)

Where it is running

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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