FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
NCT ID: NCT02392429
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
87 participants
INTERVENTIONAL
2016-04-20
2026-02-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (anthracycline, cytarabine, FLT PET/CT)
Patients receive anthracycline 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.
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
Chemotherapy
Given anthracycline IV
Computed Tomography
Undergo FLT PET/CT
Cytarabine
Given IV
Fluorothymidine F-18
Undergo FLT PET/CT
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo FLT PET/CT
Interventions
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Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
Chemotherapy
Given anthracycline IV
Computed Tomography
Undergo FLT PET/CT
Cytarabine
Given IV
Fluorothymidine F-18
Undergo FLT PET/CT
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo FLT PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have previously untreated AML and be candidates for intensive induction chemotherapy; patients are allowed to have had prior hydroxyurea
* Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years)
* Patients must have left ventricular ejection fraction (LVEF) \> 45% or within institutional normal limits
* Patients must be able to lie still for a 1.5 hour PET scan
* Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine
* Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center
* The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined
* Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Robert Jeraj
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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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
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2015-00328
Identifier Type: -
Identifier Source: org_study_id
NCI-2015-00328
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAI141
Identifier Type: -
Identifier Source: secondary_id
EAI141
Identifier Type: OTHER
Identifier Source: secondary_id
EAI141
Identifier Type: OTHER
Identifier Source: secondary_id
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