Back to search results

Understanding Bone Marrow Changes in Leukemia Treatment

This study is looking at how treatments for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) affect your bone marrow. Researchers will use special imaging techniques, like Dual-Energy Computed Tomography (DECT) and Magnetic Resonance Imaging (MRI), along with a special PET scan called Fluorothymidine F-18 (FLT PET). They will also collect bone marrow and blood samples. The goal is to better understand how total body irradiation (TBI) and chemotherapy change the bone marrow over time. This information could help doctors improve future treatments. The study aims to enroll 82 participants.

Study design
This is an interventional study, meaning you will receive specific procedures and tests. It involves two groups of participants, and the planned enrollment is 82 people.
What's involved
You would undergo various imaging scans (DECT, MRI, and potentially FLT PET) and have bone marrow and blood samples collected at different times, including at the start, at 30 and 100 days, at 1 year, and if your leukemia returns.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess changes in your bone marrow for up to 1 year after a stem cell transplant and for up to 2 years for other measures.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03422731

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

Active, Not Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
City of Hope Medical Center
~82 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDual-Energy Computed TomographyFluorothymidine F-18Laboratory Biomarker AnalysisMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change over time in cellularity and adiposity
Measured over Up to 1 year post-hematopoietic stem cell transplant (HCT)
+5 more outcomes measured

Conditions

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeffrey Y Wong · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

What this trial measures

  • Change over time in cellularity and adiposityUp to 1 year post-hematopoietic stem cell transplant (HCT)

    A non-parametric smoothing plot will be produced in the first step to view changes in the trend. Measurements will be summarized by mean +/- standard deviation (SD) at each time point. Exploratory within subjects' correlation will be examined using Pearson correlation between adjacent time points. A random-effects model will also be used to investigate whether there is significant time trend. Will use a two-sample t-test for comparing bone marrow cellularity percentage at pre-HCT and 1-year post-HCT between the total marrow and lymphoid irradiation (TMLI) group and total body irradiation (TBI) group (all cohorts). A paired t-test will also be carried out to examine if there is significant difference in changes of cellularity between these two groups.

  • Change over time of red marrow (cellularity) and yellow marrow (adipocyte)Up to 2 years

    A non-parametric smoothing plot will be produced in the first step to view changes in the trend. Measurements will be summarized by mean +/- SD at each time point. Exploratory within subjects' correlation will be examined using Pearson correlation between adjacent time points. A random-effects model will also be used to investigate whether there is significant time trend. In addition, bone marrow/peripheral blood measurements will be correlated with survival outcome (relapse).

  • Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis)Up to 2 years

    Will be assessed by HSCs from marrow aspirate.

  • Ratio of HSC sub-populations (sub-analysis)Up to 2 years

    Long-term, short-term, multi-potent progenitor, common myeloid progenitor, and granulocyte macrophage progenitor will all be assessed by HSCs marrow aspirate.

  • Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis)Up to 2 years

    Will be assessed by CD34 staining.

  • Microvascular density in bone marrow biopsy samples (sub-analysis)Up to 2 years

    Will be assessed by CD31 staining.