FLT PET / CT in Measuring Response in Patients with Previously Untreated Acute Myeloid Leukemia
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)
Alabama
Birmingham
Minnesota
Rochester
Missouri
Saint Louis
New York
New York
North Carolina
Chapel Hill
Oklahoma
Oklahoma City
Pennsylvania
Philadelphia
Tennessee
Nashville
Texas
Dallas
Utah
Salt Lake City
Wisconsin
Madison
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 FLT PET/CT at complete remission detection.
III. To evaluate pre-treatment FLT PET/CT activity as a predictor of complete remission.
IV. To evaluate the change between pre-treatment and post-treatment FLT PET/CT activity as a predictor of complete remission.
V. To correlate post-treatment FLT PET/CT imaging parameters with day 28 bone marrow aspirate/biopsy and minimal residual disease assessment by flow cytometry.
VI. To correlate FLT PET/CT imaging parameters (maximum FLT uptake across the total bone marrow compartment [SUVmax], mean FLT uptake across the total bone marrow compartment [SUVmean], heterogeneity) with biologic correlates (minimal residual disease [MRD] assessment).
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.
After completion of study, patients are followed up at day 28-35.
Trial Phase Phase II
Trial Type Diagnostic
Lead Organization
ECOG-ACRIN Cancer Research Group
Principal Investigator
Robert Jeraj
- Primary ID EAI141
- Secondary IDs NCI-2015-00328
- Clinicaltrials.gov ID NCT02392429