S9031-S9126-S9333-S9500-A, Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia

NCT ID: NCT00899171

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-09-30

Brief Summary

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.

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.

Conditions

Leukemia

Study Design

• Study Time Perspective: RETROSPECTIVE

Interventions

DNA analysis

Intervention Type: GENETIC

DNA methylation analysis

Intervention Type: GENETIC

RNA analysis

Intervention Type: GENETIC

gene expression analysis

Intervention Type: GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek L. Stirewalt, MD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Cheryl L. Willman, MD

Role: STUDY_CHAIR

University of New Mexico Cancer Center

References

Ho PA, Kopecky KJ, Alonzo TA, Gerbing RB, Miller KL, Kuhn J, Zeng R, Ries RE, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Godwin JE, Reaman GH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG. Blood. 2011 Oct 27;118(17):4561-6. doi: 10.1182/blood-2011-04-348888. Epub 2011 Aug 26.

Reference Type: BACKGROUND

PMID: 21873548 (View on PubMed)

Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.

Reference Type: DERIVED

PMID: 25527568 (View on PubMed)

Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.

Reference Type: DERIVED

PMID: 24383844 (View on PubMed)

Other Identifiers

S9031-S9126-S9333-S9500-A

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S9031-S9126-S9333-S9500-A

Identifier Type: -

Identifier Source: org_study_id