Pilot Imaging Study of Leukemia

This prospective trial is designed to evaluate whether investigational 18F FLT imaging can
identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis
in medullary spaces) and objectively (by SUV determination, secondary endpoint).

This study will enroll patients onto two arms:

For Group A Patients (post TAA-L cells or other immunotherapy): Patients will be imaged
within one week prior to receiving TAA-L cells: termed Baseline Scan and then imaged 28 days
after cellular therapy infusion (+14/-7 after infusion of cellular therapy) termed Follow-up
scan.

For Group B Patients (after other therapies): Patients will be imaged within one week prior
to starting cancer therapy: termed Baseline Scan and then imaged 28 days after cancer therapy
termed Follow-up scan as per appendix F (+14/-7 from start of chemotherapy or radiotherapy
regimen).

All scans will be coded and analyzed centrally at University of Oklahoma.

Patients will be recruited from the blood and marrow transplant and oncology clinics at both
institutions by the treating physicians who may identify whether this study is appropriate to
bring to the attention of the patient and/or his or her guardians.

Baseline 18F FLT scans will be obtained within 14 days of standard of care clinical restaging
and up to 7 days prior to initiating either immunotherapy (arm A) or standard cancer therapy
(arm B). Note: standard of care clinical restaging includes the tests performed to evaluate
the cancer disease (e.g. bone marrow, lumbar puncture, clinical imaging tests). Patients will
then receive scheduled treatment plan (Arm A TAA-L infusion, Arm B other treatments). For
patients receiving TAA-L cells at Children's National Medical Center but imaging at
University of Oklahoma, the baseline scan will be performed, the patient will travel to
Children's for the infusion and then the patient will receive follow-up scan at University of
Oklahoma. Patients will receive scheduled clinical follow-up with clinical restaging bone
marrow tests (to include minimal residual disease testing by flow and if applicable also by
PCR or FISH modalities), and if clinically indicated, restaging with CNS evaluation, or other
tests such as PET/CT for evaluation of extramedullary disease. Follow-up will occur weekly to
assess for toxicities of 18F FLT imaging for 4 weeks. The next (and final) 18F FLT image will
occur 4-8 weeks after initiation of treatment for the cancer and is planned to occur at the
time of clinical restaging for response to therapy (+ 14 days/-5 days).

Inclusion Criteria:

- Aged 4 to 80 years

- Evidence of high risk hematopoietic malignancy with relapsed/refractory disease and/or
high risk for relapse.

o Acute lymphocytic leukemia, Acute myeloid leukemia, Chronic myelogenous leukemia,
Ambiguous lineage leukemia or lymphoma, or myelodysplastic syndrome

- Karnofsky/Lansky score of ≥ 50

- Agree to use contraceptive measures during study protocol participation (when age
appropriate)

- Patient or parent/guardian capable of providing informed consent.

- Bilirubin < 2.5 mg/dL, AST/ALT <5x upper limit of normal, Serum creatinine < 1.0 or 2x
the upper limit of normal (whichever is higher)

- Pulse oximetry of > 90% on room air

- Ability to undergo 18F FLT imaging without sedation

- Anticipated immunotherapy (Arm A to include patients who received immune therapy with
TAA-L cells (RESOLVE co-enrollment) or other immunotherapy) and ARM B, those who
received other non-immune therapies to treat their cancers (excludes HSCT but includes
chemotherapy or non-HSCT radiotherapy).

Exclusion Criteria:

- Patients with uncontrolled infections

- Pregnancy or lactating

- History of prior fluorothymidine allergy or intolerance