FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02392429
• Other study ID #: NCI-2015-00328
• Secondary ID: NCI-2015-00328EA
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 20, 2016
• Est. completion date: February 13, 2025

Study information

• Verified date: March 2024
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: February 13, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• 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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection
• Bone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
• Bone Marrow Biopsy
Undergo bone marrow biopsy and aspiration

Drug:
• Chemotherapy
Given anthracycline IV

Procedure:
• Computed Tomography
Undergo FLT PET/CT

Drug:
• Cytarabine
Given IV

Other:
• Fluorothymidine F-18
Undergo FLT PET/CT
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Positron Emission Tomography
Undergo FLT PET/CT

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value of post-treatment fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) imaging for complete remission (CR) in comparison with blast counts from bone marrow biopsy (BMBX)	Three imaging parameters (standardized uptake value [SUV]mean, SUVmax, heterogeneity of FLT uptake [SUVhetero]) will be measured from an FLT PET/CT scan and SUVmax will be the primary endpoint. The binomial proportion of negative predictive value (NPV) and the corresponding exact confidence intervals will be calculated. In addition, the calculated NPV will be tested against the null hypothesis to see if it's significantly larger than 0.64 (NPV of day-14 BMBX in CR prediction).	Up to day 35
Secondary	Positive predictive value (PPV) of post-treatment FLT PET/CT imaging for complete remission	The binomial proportion of PPV and the corresponding exact confidence intervals will be calculated. In addition, the calculated PPV will be tested to see if it's significantly larger than 0.79 (PPV of day-14 BMBX in CR prediction).	Up to day 35
Secondary	Sensitivity of post-treatment FLT PET/CT for detecting complete remission	The binomial proportions and the corresponding exact confidence intervals will be calculated for sensitivity estimation.	Up to day 35
Secondary	Specificity of post-treatment FLT PET/CT for detecting complete remission	The binomial proportions and the corresponding exact confidence intervals will be calculated for specificity estimation.	Up to day 35
Secondary	FLT PET/CT imaging parameters with biologic correlates (minimal residual disease assessment)	Will be assessed by correlation and regression analysis.	Up to day 35
Secondary	FLT PET/CT imaging parameters with relapse-free survival	Will be assessed by Kaplan-Meier method and Cox proportional hazard regression.	Up to day 35
Secondary	FLT PET/CT imaging parameters with overall survival	Will be assessed by Kaplan-Meier method and Cox proportional hazard regression.	Up to day 35