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NCT03422731 | RECRUITING | Acute Lymphoblastic Leukemia

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

City of Hope Medical Center

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.

Condition or disease

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Intervention/treatment

Biospecimen Collection

Dual-Energy Computed Tomography

Fluorothymidine F-18

Laboratory Biomarker Analysis

Magnetic Resonance Imaging

Positron Emission Tomography

Phase

EARLY_PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 74 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Multi-Modality Imaging and Correlative Studies in Patients With Leukemia
Actual Study Start Date : 2018-02-15
Estimated Primary Completion Date : 2025-11-06
Estimated Study Completion Date : 2025-11-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy

Location Details

NCT03422731

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Locations

RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91010