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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 35

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

FLT PET/CT imaging parameters with biologic correlates (minimal residual disease assessment)

FLT PET/CT imaging parameters with overall survival

FLT PET/CT imaging parameters with relapse-free survival

+3 more

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

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Positron Emission Tomography

2008

Completed Phase 2

~2240

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1730

Chemotherapy

2003

Completed Phase 4

~3050

Cytarabine

2016

Completed Phase 3

~3310

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,066 Total Patients Enrolled

Robert JerajPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02392429 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Diagnostic (anthracycline, cytarabine, FLT PET/CT)

Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT02392429 — Phase 2

Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02392429 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which medical cases is Chemotherapy traditionally employed?

"Leptomeningeal metastases is frequently treated with Chemotherapy, but this treatment can also be applied to a variety of other conditions such as acute promyelocytic leukemia, meningeal leukemia and blast phase chronic myelocytic leukemia."

Answered by AI

To what degree can chemotherapy be administered without incurring health risks?

"Chemotherapy received a score of 2 on the safety scale given that it is currently undergoing Phase 2 trials and there is evidence to support its safety but not yet efficacy."

Answered by AI

What is the aggregate size of the cohort participating in this research endeavor?

"This clinical trial has concluded its recruitment process. It was initially posted on December 8th 2015 and last updated November 8th 2022. If you are still in search of other trials, there presently exist 1,532 studies for leukemia and myelocytic acute looking for participants as well as 234 Chemotherapy related investigations actively recruiting patients."

Answered by AI

How many healthcare facilities are participating in the trial within the locality?

"At present, 13 medical centres are recruiting participants for this trial. These establishments can be found in Philadelphia, Oklahoma City, Madison and other cities across the US; hence it is recommended that prospective patients select the closest site to minimize travel needs."

Answered by AI

Are there any spots still available for participants in this research program?

"This experiment, which was initially announced on 8th December 2015 and updated most recently on 8th November 2022, is no longer recruiting. Nonetheless, 1766 other medical trials are at present seeking out participants."

Answered by AI

Could you outline any other experiments that have been conducted exploring the efficacy of Chemotherapy?

"Presently, 234 trials for Chemotherapy are still running with 60 of them in the last stage. While many clinical studies can be found within New york City, there is an expansive network of 9778 sites across the globe offering chemotherapy studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia

2016. "FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02392429.

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