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Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging
This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.
PRIMARY OBJECTIVES: I. To evaluate the negative predictive value (NPV) of post-treatment FLT PET/CT imaging for complete remission (CR) in patients receiving induction chemotherapy for acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. To evaluate the positive predictive value (PPV) of post-treatment FLT PET/CT imaging for complete remission. II. To estimate the sensitivity and specificity of post-treatment FLT PET/CT imaging for detecting complete remission. III. To correlate FLT PET/CT imaging with biologic correlates (minimal residual disease \[MRD\] assessment) IV. To correlate FLT PET/CT imaging with relapse-free survival and overall survival. EXPLORATORY OBJECTIVES: III. To evaluate pre-treatment FLT PET/CT imaging as a predictor of complete remission. IV. To evaluate the change between pre-treatment and post-treatment FLT PET/CT imaging as a predictor of complete remission. OUTLINE: Patients receive anthracycline intravenously (IV) on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial. After completion of study, patients are followed up at day 28-35, and then up to 1 year beyond the end of study accrual period.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai Hospital
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Start Date
April 20, 2016
Primary Completion Date
December 31, 2023
Completion Date
February 13, 2027
Last Updated
March 20, 2026
87
ACTUAL participants
Biospecimen Collection
PROCEDURE
Bone Marrow Aspiration
PROCEDURE
Bone Marrow Biopsy
PROCEDURE
Chemotherapy
DRUG
Computed Tomography
PROCEDURE
Cytarabine
DRUG
Fluorothymidine F-18
OTHER
Laboratory Biomarker Analysis
OTHER
Positron Emission Tomography
PROCEDURE
Lead Sponsor
National Cancer Institute (NCI)
NCT06285890
NCT06220162
NCT04065399
Data Source & Attribution
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