Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
NCT ID: NCT03422731
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
74 participants
INTERVENTIONAL
2018-02-15
2026-11-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort I (TMLI+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.
Biospecimen Collection
Undergo collection of bone marrow and blood samples
Dual-Energy Computed Tomography
Undergo DECT
Fluorothymidine F-18
Undergo FLT PET
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo water-fat MRI
Positron Emission Tomography
Undergo FLT PET
Cohort II (TBI)
Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.
Biospecimen Collection
Undergo collection of bone marrow and blood samples
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Biospecimen Collection
Undergo collection of bone marrow and blood samples
Dual-Energy Computed Tomography
Undergo DECT
Fluorothymidine F-18
Undergo FLT PET
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo water-fat MRI
Positron Emission Tomography
Undergo FLT PET
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Y Wong
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2017-01778
Identifier Type: REGISTRY
Identifier Source: secondary_id
17222
Identifier Type: OTHER
Identifier Source: secondary_id
17222
Identifier Type: -
Identifier Source: org_study_id
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