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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Alovudine; Dideoxynucleosides

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)