Spots Global Cancer Trial Database for FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
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Trial Identification
Brief Title: FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
Official Title: Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging
Study ID: NCT02392429
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint 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
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Robert Jeraj
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR
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