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

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.

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)