Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245231
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment
Leukemia Genetic: protein expression analysis Genetic: western blotting Other: flow cytometry Other: laboratory biomarker analysis Other: medical chart review

Detailed Description:



  • 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.


  • 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
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II
Study Start Date : May 2010
Actual Primary Completion Date : May 2016

Primary Outcome Measures :
  1. Correlation of constitutive pStat3 with inducible pStat3
  2. Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
  3. Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
  4. Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1

Secondary Outcome Measures :
  1. Correlation between pStat3/pStat5 and event-free survival and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia (AML)


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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245231

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Michele S. Redell, MD, PhD Texas Children's Cancer Center

Responsible Party: Children's Oncology Group Identifier: NCT01245231     History of Changes
Other Study ID Numbers: AAML11B6
COG-AAML11B6 ( Other Identifier: Children's Oncology Group )
CDR0000689410 ( Other Identifier: Clinical )
NCI-2011-02845 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia/other myeloid malignancies

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid