Clinical trial NCT03422731: Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
Official title: Multi-Modality Imaging and Correlative Studies in Patients With Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradiation (TBI) and chemotherapy. Using multi-modality imaging and collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can change the bone marrow.

Detailed description: 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. Feasibility of fluorothymidine F-18 (FLT) positron emission tomography (PET) imaging biomarker as a predictor of treatment response.

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

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I (TLMI+FLT/TMLI): Patients may undergo optional fluorothymidine F-18 PET scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. Patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. Patients undergo fluorothymidine F-18 PET, DECT, and water-fat MRI as in TMLI+FLT.

COHORT II (TBI): Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.

Eligibility criteria: Inclusion Criteria:

* Cohort TMLI+FLT: AML patients eligible for and enrolling on COH 14012 or IRB 17505 that agree to participate in optional FLT PET imaging

  * Note: patients enrolling on IRB 19518 cannot enroll onto this cohort, but they may enroll on Cohort TMLI (below)
* Cohort TMLI: AML or ALL patients eligible for and enrolling on COH 14012, IRB 17505 or IRB 19518
* Cohort TBI: First or second remission AML or ALL 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

Primary outcomes:
measure: Change over time in cellularity and adiposity
timeFrame: Up to 1 year post-hematopoietic stem cell transplant (HCT)
measure: Change over time of red marrow (cellularity) and yellow marrow (adipocyte)
timeFrame: Up to 2 years
measure: Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis)
timeFrame: Up to 2 years
measure: Ratio of HSC sub-populations (sub-analysis)
timeFrame: Up to 2 years
measure: Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis)
timeFrame: Up to 2 years
measure: Microvascular density in bone marrow biopsy samples (sub-analysis)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Standardized uptake value (SUV) distribution at different skeletal sites
timeFrame: Baseline
measure: SUV distribution and presence of focal hot spot
timeFrame: Baseline
measure: Change in FLT PET activity
timeFrame: Baseline up to 2 years
measure: SUVmax at site of biopsy
timeFrame: At time of biopsy
measure: SUVmean at site of biopsy
timeFrame: At time of biopsy
measure: Blast counts
timeFrame: Up to 2 years
measure: SUVmax at iliac crest, lumber spine, and femur
timeFrame: Up to 2 years
measure: SUVmean at iliac crest, lumber spine, and femur
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Jeffrey Y Wong
role: PRINCIPAL_INVESTIGATOR
References: