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Imaging and Biospecimen Collection for Acute Myeloid Leukemia

Phase < 1

Recruiting

Led By Jeffrey Y Wong

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort TBI: Patients who have not received a prior transplant

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates how TBI and chemotherapy affects bone marrow by looking at changes via imaging and collecting patient samples.

Who is the study for?

This trial is for adults aged 18-60 with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who are in their first or second remission and haven't had a prior transplant. They must be eligible for certain other studies, consent to participate, and agree to undergo specific imaging if enrolling on COH 14012 or IRB 17505.

What is being tested?

The study is examining how total body irradiation (TBI) combined with chemotherapy affects bone marrow changes in AML/ALL patients. It involves advanced imaging techniques like Dual-Energy CT, MRI, PET scans using Fluorothymidine F-18, and collecting biospecimen samples.

What are the potential side effects?

Potential side effects may include reactions related to the imaging agents used such as allergic reactions or discomfort at the injection site. Chemotherapy and TBI can cause fatigue, nausea, hair loss, infection risk increase, bleeding complications, and damage to organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had a transplant before.

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I have AML or ALL in first or second remission and will get TBI with chemotherapy as standard care.

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I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change over time in cellularity and adiposity

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

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

+3 more

Secondary study objectives

Blast counts

SUV distribution and presence of focal hot spot

SUVmax at iliac crest, lumber spine, and femur

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort I (TMLI+FLT/TMLI)Experimental Treatment6 Interventions

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.

Group II: Cohort II (TBI)Active Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Dual-Energy Computed Tomography

2018