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

NCT03422731 | Recruiting Early Phase 1 DMC FDA Drug

• 3 other identifiers: 17222NCI-2017-01778P30CA033572
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (6)

• Change over time in cellularity and adiposity

  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.

  Up to 1 year post-hematopoietic stem cell transplant (HCT)

• Change over time of red marrow (cellularity) and yellow marrow (adipocyte)

  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).

  Up to 2 years

• Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis)

  Will be assessed by HSCs from marrow aspirate.

  Up to 2 years

• Ratio of HSC sub-populations (sub-analysis)

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

  Up to 2 years

• Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis)

  Will be assessed by CD34 staining.

  Up to 2 years

• Microvascular density in bone marrow biopsy samples (sub-analysis)

  Will be assessed by CD31 staining.

  Up to 2 years

Secondary Outcomes (8)

• Standardized uptake value (SUV) distribution at different skeletal sites

  Baseline

• SUV distribution and presence of focal hot spot

  Baseline

• Change in FLT PET activity

  Baseline up to 2 years

• SUVmax at site of biopsy

  At time of biopsy

• SUVmean at site of biopsy

  At time of biopsy

Study Arms (2)

Cohort I (TMLI+FLT/TMLI)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Dual-Energy Computed Tomography; Drug: Fluorothymidine F-18; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Cohort II (TBI)

ACTIVE COMPARATOR

Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.

Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of bone marrow and blood samples

Cohort I (TMLI+FLT/TMLI); Cohort II (TBI)

Dual-Energy Computed Tomography PROCEDURE

Undergo DECT

Also known as: DECT

Cohort I (TMLI+FLT/TMLI)

Fluorothymidine F-18 DRUG

Undergo FLT PET

Also known as: 18F-FLT, 3''-Deoxy-3''-(18F) Fluorothymidine, 3''-deoxy-3''-[18F]fluorothymidine, ALOVUDINE F-18, Fluorothymidine F 18

Cohort I (TMLI+FLT/TMLI)

Laboratory Biomarker Analysis OTHER

Correlative studies

Cohort I (TMLI+FLT/TMLI); Cohort II (TBI)

Magnetic Resonance Imaging PROCEDURE

Undergo water-fat MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Cohort I (TMLI+FLT/TMLI)

Positron Emission Tomography PROCEDURE

Undergo FLT PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Cohort I (TMLI+FLT/TMLI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

alovudine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey Y Wong

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: February 6, 2018
• Study Start: February 15, 2018
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)