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

Status: Active

Description

This pilot clinical trial studies 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 mutli-modality imaging and collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can change the bone marrow.

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
  • Cohort TMLI: AML or ALL patients eligible for and enrolling on COH 14012 or IRB 17505
  • 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

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Jeffrey Y.C. Wong
Phone: 626-218-2247
Email: jwong@coh.org

Trial Objectives and Outline

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, at 1 year, and at time of relapse. 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, at time of relapse, and at 1 year.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Basic science

Lead Organization

Lead Organization
City of Hope Comprehensive Cancer Center

Principal Investigator
Jeffrey Y.C. Wong

Trial IDs

Primary ID 17222
Secondary IDs NCI-2017-01778
Clinicaltrials.gov ID NCT03422731