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Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
NCT03422731 · City of Hope Medical Center
In plain English
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Official title
Multi-Modality Imaging and Correlative Studies in Patients With Leukemia
About this study
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
Study design
Enrollment target: 74 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-02-15
Estimated completion: 2026-11-06
Last updated: 2026-04-15
Interventions
Procedure: Biospecimen CollectionProcedure: Dual-Energy Computed TomographyDrug: Fluorothymidine F-18Other: Laboratory Biomarker AnalysisProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
Primary outcomes
- • Change over time in cellularity and adiposity (Up to 1 year post-hematopoietic stem cell transplant (HCT))
- • Change over time of red marrow (cellularity) and yellow marrow (adipocyte) (Up to 2 years)
- • Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis) (Up to 2 years)
Sponsor
City of Hope Medical Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorJeffrey Y Wong · principal_investigator, City of Hope Medical Center
All locations (1)
City of Hope Medical CenterRecruiting
Duarte, California, United States