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Anti-metabolites

FLT PET/CT Imaging for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Robert Jeraj

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must be able to lie still for a 1.5 hour PET scan

Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 35 and up to 4 years for rfs

Awards & highlights

No Placebo-Only Group

Summary

This trial uses FLT PET/CT to measure response in patients with newly diagnosed AML.

Who is the study for?

This trial is for adults with newly diagnosed acute myeloid leukemia who haven't been treated yet. They must be able to lie still for a PET scan, not be pregnant or breastfeeding, and have no history of allergic reactions to similar compounds as the study drug. Participants need a good performance status and heart function, can't weigh more than the scanner limit, and shouldn't have certain types of leukemia.

What is being tested?

The trial tests how well FLT PET/CT scans measure treatment response in patients receiving their first round of chemotherapy for acute myeloid leukemia. FLT is a radioactive tracer that highlights dividing cells like cancer on scans.

What are the potential side effects?

Potential side effects may include reactions related to the injection of the radioactive substance (FLT), such as discomfort at the injection site or allergic reactions. The chemotherapy involved can cause various side effects ranging from nausea to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I can stay still for 1.5 hours during a scan.

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I do not have acute promyelocytic leukemia or the specific genetic abnormality t(15;17).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 35 and up to 4 years for rfs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 35 and up to 4 years for rfs

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 35 and up to 4 years for rfs for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Negative Predictive Value of Post-treatment Fluorothymidine F 18 (FLT) Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging for Complete Remission (CR) in Comparison With Blast Counts From Bone Marrow Biopsy (BMBX)

Secondary study objectives

FLT PET/CT Imaging Parameters With Biologic Correlates (Minimal Residual Disease Assessment)

FLT PET/CT Imaging to Predict Overall Survival

FLT PET/CT Imaging to Predict Relapse-free Survival

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (anthracycline, cytarabine, FLT PET/CT)Experimental Treatment9 Interventions

Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Bone Marrow Aspiration

2011

Completed Phase 2

~1740