S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059734
• Other study ID #: S9031-S9126-S9333-S9500-B
• Secondary ID: S9031-S9126-S933
• Status: Completed
• Phase: N/A
• First received: January 29, 2010
• Last updated: March 5, 2015
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

PURPOSE: This research study is looking at biomarker expression in bone marrow samples from patients with acute myeloid leukemia.

Description:

OBJECTIVES:

• Estimate the distributions of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms (SNPs) in patients with newly diagnosed acute myeloid leukemia (AML).

• Estimate the distributions of mutations in TOP2 phosphorylation sites (by SNP analysis) in these patients.

• Investigate whether expression of TOP2 or mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in these patients.

• Test whether TOP2 expression correlates with complete remission rates, relapse-free survival, and overall survival of these patients.

• Conduct preliminary analyses to estimate the distributions of TOP2 expression and mutations in TOP2 phosphorylation sites (by SNP analysis) in patients with relapsed and/or refractory AML.

• Investigate whether expression of TOP2 and mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in patients with relapsed and/or refractory AML.

• Test whether TOP2 expression and mutations in TOP2 phosphorylation sites differ between previously untreated and relapsed/refractory AML patients.

OUTLINE: This is a multicenter study.

Archived RNA specimens are analyzed for topoisomerase 2 transcriptional expression by quantitative real-time polymerase chain reaction (PCR) and for mutations within TOP2 phosphorylation sites by single nucleotide polymorphism analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia

• All subtypes allowed (except acute promyelocytic leukemia [M3])

• Previously untreated OR relapsed/refractory disease

• Isolated RNA specimens from bone marrow aspirate samples available from patients who participated on SWOG-9031, SWOG-9333 (cytarabine/daunorubicin hydrochloride induction arm only), SWOG-9500, or SWOG-9126

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• DNA analysis

• RNA analysis

• mutation analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms		immediate	No
Primary	Distributions of mutations in TOP2 phosphorylation sites		immediate	No
Primary	Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival		immediate	No
Primary	Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics		immediate	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database