Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898456
First received: May 9, 2009
Last updated: September 10, 2011
Last verified: September 2011

May 9, 2009
September 10, 2011
October 2006
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  • Correlation of common single nucleotide polymorphisms (SNPs) and haplotypes of the 3 multidrug resistance genes (P-glycoprotein [Pgp], multidrug resistance-associated protein (MRP-1) and breast cancer resistance protein [BCRP]) with treatment outcome [ Designated as safety issue: No ]
  • Effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms on treatment outcome [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00898456 on ClinicalTrials.gov Archive Site
  • Association of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes with Pgp, MRP-1, and BCRP function and expression in pre-treatment blasts [ Designated as safety issue: No ]
  • Effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function [ Designated as safety issue: No ]
  • Association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity [ Designated as safety issue: No ]
  • Association of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes with Pgp, MRP-1, and BCRP function and expression in pre-treatment blasts [ Designated as safety issue: No ]
  • Effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function [ Designated as safety issue: No ]
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Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia
Multidrug Resistance Protein Gene Polymorphisms in Acute Myeloid Leukemia. A CALGB Leukemia Tissue Bank Project

RATIONALE: Studying samples of bone marrow or blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about drug resistance and how patients respond to treatment.

PURPOSE: This laboratory study is looking at multidrug resistance genes in patients with acute myeloid leukemia.

OBJECTIVES:

Primary

  • Correlate common single nucleotide polymorphisms (SNPs) and haplotypes of the 3 multidrug resistance genes (P-glycoprotein [Pgp], multidrug resistance-associated protein (MRP-1), and breast cancer resistance protein [BCRP]) with treatment outcome in patients with acute myeloid leukemia (AML).
  • Determine the effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in younger patients enrolled on CALGB-9621 or CALGB-19808.
  • Determine the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in older patients enrolled on CALGB 9720.

Secondary

  • Determine whether ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes are associated with Pgp, MRP-1, and BCRP function and expression in pre-treatment blasts from patients with AML.
  • Determine the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function, according to the methods used in CALGB-9760, in younger patients enrolled on CALGB-9621 or CALGB-19808.
  • Determine the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function, according to the methods used in CALGB-9760, in older patients enrolled on CALGB-9720.
  • Conduct an exploratory analysis of the association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity.

OUTLINE: This is a multicenter, retrospective study.

Leukemia blast cells obtained from bone marrow aspirate or peripheral blood at diagnosis are used to study polymorphisms and haplotypes of ATP-binding cassette (ABC) B1, ABCC1, ABCG2, and other candidate genes. Multidrug resistance (MDR) protein expression and function are also analyzed using leukemia blast cells from patients enrolled on CALGB-9760.

PROJECTED ACCRUAL: Tissue samples from over 600 patients will be accrued for this study.

Observational
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Leukemia
  • Genetic: gene expression analysis
  • Genetic: molecular genetic technique
  • Genetic: polymorphism analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia
  • Treated on protocols CALGB-9621, CALGB-9720, or CALGB-19808
  • Registered on the mandatory companion Leukemia Tissue Bank Protocol CALGB-9665

    • Registration on another companion trial, CALGB-9760, (Multidrug Resistance Studies in Acute Leukemia) allowed

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
15 Years and older
No
United States
 
NCT00898456
CDR0000514506, CALGB-20501
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Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Maria R. Baer, MD University of Maryland Greenebaum Cancer Center
Investigator: Deanna L. Kroetz, PhD University of California, San Francisco
National Cancer Institute (NCI)
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP