Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

May 17, 2016 updated by: Children's Oncology Group

Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying prognostic biomarkers in cell samples from young patients with acute myeloid leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway activity.
  • To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low- and high-doses of cytokines.
  • To evaluate the expression levels of Stat3 protein and the upstream and downstream regulators of Stat3 activation.

Secondary

  • To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).

OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.

Study Type

Observational

Enrollment (Anticipated)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of acute myeloid leukemia (AML)

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Cryopreserved AML specimens

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Correlation of constitutive pStat3 with inducible pStat3
Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1

Secondary Outcome Measures

Outcome Measure
Correlation between pStat3/pStat5 and event-free survival and overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michele S. Redell, MD, PhD, Texas Children's Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML11B6
  • COG-AAML11B6 (Other Identifier: Children's Oncology Group)
  • CDR0000689410 (Other Identifier: Clinical Trials.gov)
  • NCI-2011-02845 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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