18-FLT PET / MRI in Predicting Graft Failure and Graft Versus Host Disease in Patients Undergoing Bone Marrow or Stem Cell Transplant

Status: Active

Description

This early phase I trial studies how well fluorothymidine F-18 (18-FLT) positron emission tomography (PET) / magnetic resonance imaging (MRI) works in predicting graft failure and graft versus host disease in patients who are undergoing a bone marrow or stem cell transplant. FLT is a PET tracer that is used to image areas with high rates of cell division. Giving FLT with diagnostic procedures, such as PET / MRI, may help predict bone marrow transplant success, malignancy relapse, and the development of graft versus host disease.

Eligibility 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.
  • Able to provide informed consent.
  • Negative urine pregnancy test in women of child-bearing potential.

Exclusion Criteria

  • Subjects meeting any of the exclusion criteria at baseline will be excluded from participating in this study.
  • 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.
  • 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 MRI scans will be obtained in the outpatient setting).

Locations & Contacts

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Yueh Lee
Phone: 919-537-3730
Email: leey@med.unc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare the overall FLT-PET bone marrow signal on transplant day +25 between allogeneic stem cell transplant recipients who do and do not go on to achieve complete donor bone marrow reconstitution by transplant day +35.

II. To compare the overall FLT-PET signal intensity within host secondary lymphoid sites on transplant day +60 between allogeneic stem cell transplant recipients who do and do not develop acute graft versus host disease (GVHD) by transplant day +100.

SECONDARY OBJECTIVES:

I. To compare the overall FLT-PET bone marrow signal on transplant day +60 between allogeneic stem cell transplant recipients who do and do not achieve complete donor bone marrow reconstitution by transplant day +100.

II. To compare the overall FLT-PET signal intensity within host secondary lymphoid sites on transplant day +25 between allogeneic stem cell transplant recipients who do and do not develop acute GVHD by transplant day +100.

III. To evaluate differences in FLT uptake within the bone marrow and secondary lymphoid tissues in patients undergoing autologous hematopoietic cell transplantation (HSCT) versus allogeneic HSCT.

IV. To correlate the strength of the FLT-PET signal within the bone marrow on transplant day +25 with the rate of transfusion independence on transplant day +35 in allogeneic stem cell transplant recipients.

V. To correlate the strength of the FLT-PET signal within the bone marrow on transplant day +25 with bone marrow cellularity on transplant day +35 in allogeneic stem cell transplant recipients.

VI. To correlate the strength of the FLT-PET signal within the bone marrow on transplant day +60 with the rate of transfusion independence on transplant day +100 in allogeneic stem cell transplant recipients.

VII. To correlate the strength of the FLT-PET signal within the bone marrow on transplant day +60 with bone marrow cellularity on transplant day +100 in allogeneic stem cell transplant recipients.

VIII. To evaluate if isolated or asymmetric foci of increased FLT within the bone marrow or lymph nodes on transplant day +60 are associated with the incidence of disease relapse by day +100 in allogeneic stem cell transplant recipients.

IX. To correlate the strength of the FLT-PET signal within the bone marrow on transplant day +25 and on day +60 with magnetic resonance imaging (MRI) findings suggestive of engraftment in allogeneic stem cell transplant recipients.

X. To evaluate the association of the overall FLT-PET signal intensity within host secondary lymphoid sites on transplant day +60 with the overall incidence of acute graft versus host disease and malignancy relapse over the first transplant year.

OUTLINE:

Patients receive fluorothymidine F-18 intravenously (IV) and undergo PET/MRI on days 25 and 60 after transplant.

After completion of study, patients are followed up on day 100 after transplant and then periodically for up to 1 year.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
UNC Lineberger Comprehensive Cancer Center

Principal Investigator
Yueh Lee

Trial IDs

Primary ID LCCC1714
Secondary IDs NCI-2019-04889
Clinicaltrials.gov ID NCT03546556