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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01059734
First received: January 29, 2010
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: DNA analysis
Genetic: RNA analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Distributions of mutations in TOP2 phosphorylation sites [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 357
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients enrolled on S0931, S9126, S9333 or S9500 consenting to use of specimens for future research

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059734

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anjali Advani, MD The Cleveland Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01059734     History of Changes
Other Study ID Numbers: CDR0000664320, S9031-S9126-S9333-S9500-B, U10CA032102
Study First Received: January 29, 2010
Last Updated: December 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with inv(16)(p13;q22)
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 erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
 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
adult acute minimally differentiated myeloid leukemia (M0)
adult acute megakaryoblastic leukemia (M7)

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

ClinicalTrials.gov processed this record on May 21, 2013