Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Ambiguous Lineage Leukemia or Lymphoma
  • Myelodysplastic Syndrome
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective pilot study, the primary aim of which is to determine whether the abnormalities in 18F FLT imaging signal uptake correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.Masking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 4 years and 80 years
Gender
Both males and females

Description

This prospective trial is designed to evaluate whether investigational 18F FLT imaging can identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis in medullary spaces) and objectively (by SUV determination, secondary endpoint). Because patients with high risk acut...

This prospective trial is designed to evaluate whether investigational 18F FLT imaging can identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis in medullary spaces) and objectively (by SUV determination, secondary endpoint). Because patients with high risk acute leukemia, CML, and MDS have poor prognosis with high risk for relapse, novel ways to evaluate the success of therapies would be valuable. 18F FLT is 3'-deoxy-3 18F-fluorothymidine, a radiolabeled thymidine analogue, reveals hematopoietic cell proliferation, and can identify residual leukemia disease. This study will enroll patients onto two arms: For Group A Patients (post immunotherapy with co-enrollment on separate protocol or other immunotherapy): Patients will be imaged within one week prior to receiving immunotherapy: termed Baseline Scan and then imaged approximately 28 days after immunotherapy (+14/-7 days after therapy) termed Follow-up scan. For Group B Patients (after other therapies): Patients will receive their baseline scans within one week prior to starting cancer therapy and their follow up scan 28 days after cancer therapy (+14/-7 days). Baseline 18F FLT scans will be obtained within 14 days of standard of care clinical restaging and up to 7 days prior to initiating either immunotherapy (arm A) or standard cancer therapy (arm B). Patients will then receive scheduled treatment plan. Patients will receive scheduled clinical follow-up with clinical restaging bone marrow tests and if clinically indicated, restaging with CNS evaluation, or other tests such as PET/CT for evaluation of extramedullary disease. Follow-up will occur weekly to assess for toxicities of 18F FLT imaging for 4 weeks. The follow up 18F FLT image will occur 4-8 weeks after initiation of treatment for the cancer and is planned to occur at the time of clinical restaging for response to therapy (+ 14 days/-7 days). Patients will also undergo sampling for blood biomarkers of residual disease and immune activity against disease. Finally, patients will report symptoms and quality of life measures using the PROMIS measures. Patients will be recruited from the blood and marrow transplant and oncology clinics at institutions by the treating physicians who may identify whether this study is appropriate to bring to the attention of the patient and/or his or her guardians.

Tracking Information

NCT #
NCT03633955
Collaborators
Emory University
Investigators
Principal Investigator: Jennifer Holter, MD Stephenson Cancer Center