Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia

Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Cancer Institute (NCI).   Recruitment status was  Not yet recruiting

First Received on May 9, 2009.  
No Changes Posted
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00899171
  Purpose

RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow and blood samples from patients with acute myeloid leukemia.

Condition Intervention
Leukemia Genetic: DNA analysis
Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Examination of the Prognostic Significance of AML-Specific and Age-Associated Genes in AML Patients

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

  • Prognostic significance for complete response, overall survival, and relapse-free survival of total and relative expression levels (variant/wild type ratios) for each gene [ Designated as safety issue: No ]
  • Role of acute myeloid leukemia (AML)-specific and age-associated genes in the biology and prognosis of AML [ Designated as safety issue: No ]
  • Role of methylation and histone modification in IRF8 gene expression [ Designated as safety issue: No ]

Estimated Enrollment: 251
Study Start Date: November 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • To determine whether the expression of previously identified acute myeloid leukemia (AML)-specific and age-associated genes have prognostic significance in adult patients with AML.
  • To examine, preliminarily, if AML-specific and age-associated expression changes occur in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).
  • To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG island/promoter region is correlated with IRF8 gene expression in AML.

OUTLINE: This is a multicenter study.

Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays and linked to clinical and outcome data from the main SWOG database. Samples from a subset of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with methylation or histone modification of the IRF8 CPG island/promoter region.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pretreatment RNA specimens* available from patients with acute myeloid leukemia (AML) registered for front-line therapy on the following clinical trials:

    • SWOG-9031
    • SWOG-9126
    • SWOG-9333
    • SWOG-9500
  • Cryopreserved pretreatment cell specimens* available from a subset of patients (those who obtained a complete response [CR] and remained in CR without relapse for ≥ 2 years vs those with resistant disease [i.e., failed to achieve CR with evidence of persistent AML following induction therapy]) NOTE: All specimens currently available in the Southwest Oncology Group Myeloid Leukemia and MDS Repository at the University of New Mexico

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899171

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Derek L. Stirewalt, MD Fred Hutchinson Cancer Research Center
Investigator: Cheryl L. Willman, MD University of New Mexico
  More Information

Additional Information:

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00899171    
History of Changes
Other Study ID Numbers: CDR0000614113, SWOG-S9031-S9126-S9333-S9500-A
Study First Received: May 9, 2009
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
secondary acute myeloid leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2012

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