Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy

PRIMARY OBJECTIVES:

I. Temporal assessment of treatment impact on bone marrow. II. Relative assessment of bone
marrow status between total marrow and lymphoid irradiation (TMLI) and conventional TBI.

SECONDARY OBJECTIVES:

I. Correlation of dual energy computed tomography (DECT), magnetic resonance imaging (MRI)
imaging with biological samples for cellularity/adiposity.

II. Relative assessment of chimerism engraftment kinetics between TMLI and TBI. III. Relative
assessment of circulating cytokines between TMLI and TBI. IV. Feasibility of fluorothymidine
F-18 (FLT) positron emission tomography (PET) imaging biomarker as a predictor of treatment
response.

V. Correlation of FLT PET imaging with biological correlate for leukemia. VI. Characterize
relative distribution of leukemia in bone marrow (BM) environment.

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT I (TLMI+FLT): Patients may undergo optional fluorothymidine F-18 PET scan over 2 hours
at baseline, and on days -1, 30, and 60. Patients undergo DECT and water-fat MRI scan over 30
minutes at baseline, on days -1, 30, 60, and 180, and at years 1 and 2. Patients also undergo
collection of bone marrow and blood samples at baseline, on days -4, -1, 30, 60,100, and 180,
and at years 1 and 2.

COHORT II (TMLI): Patients undergo fluorothymidine F-18 PET, DECT, water-fat MRI, and
collection of bone marrow and blood samples as in Cohort I.

COHORT III (TBI): Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline
and 1 year. Patients undergo collection of bone marrow and blood samples at baseline, on days
30 and 100, and at 1 year.

Inclusion Criteria:

- Cohort TMLI+FLT: AML patients eligible for and enrolling on COH 14012 that agree to
participate in option FLT PET imaging

- Cohort TMLI: AML patients eligible for and enrolling on COH 14012

- Cohort TBI: First or second remission AML patients that will receive TBI (13.2 Gy)
plus chemotherapy (etoposide [VP16] 60 mg/kg or cyclophosphamide [Cy] 60 mg/kg for two
days) as part of their standard of care

- Cohort TBI: Documented written informed consent of participant

- Cohort TBI: Age >= 18 to =< 60 years

- Cohort TBI: Patients who have not received a prior transplant

- Cohort TBI: Patients free of any psychiatric, social or compliance issues that, in the
treating physician opinion, will interfere with the completion of the transplant
treatment and follow up