Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898456
First received: May 9, 2009
Last updated: July 23, 2015
Last verified: July 2015

May 9, 2009
July 23, 2015
October 2006
January 2100   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms on treatment outcome [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ]
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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on Pgp, MRP-1, and BCRP function [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity [ Time Frame: Baseline ] [ 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

This research trial studies multidrug resistance genes in patients with acute myeloid leukemia. 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 deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn more about drug resistance and how patients respond to treatment.

PRIMARY OBJECTIVES:

I. To investigate the association of common single nucleotide polymorphisms (SNPs) and haplotypes of the three multidrug resistance (MDR) genes with treatment outcome in the clinical studies.

II. To assess the effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in younger patients enrolled on Cancer and Leukemia Group B (CALGB) 9621 and 19808.

III. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in older patients enrolled on CALGB 9720.

SECONDARY OBJECTIVES:

I. To test the hypothesis that ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes are associated with phosphoglycolate phosphatase (Pgp), multidrug resistance protein 1 (MRP-1), and ATP-binding cassette, sub-family G (WHITE), member 2 (Junior blood group) (BCRP) function and expression in pre-treatment blasts from acute myeloid leukemia (AML) patients.

II. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on PGP, MRP-1, and BCRP function through CALGB 9760 in younger patients enrolled on CALGB 9621 and 19808.

III. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on PGP, MRP-1, and BCRP function through CALGB 9760 in older patients from CALGB 9720.

IV. To conduct an exploratory analysis of the association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity.

OUTLINE:

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
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

Patients with acute myeloid leukemia enrolled on CALGB-9621, CALGB-9720, or CALGB-19808

Leukemia
  • Genetic: gene expression analysis
  • Genetic: molecular genetic technique
  • Genetic: polymorphism analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
Group 1
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.
Interventions:
  • Genetic: gene expression analysis
  • Genetic: molecular genetic technique
  • Genetic: polymorphism analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00898456
CALGB-20501, CALGB-20501, U10CA031946, U10CA180821, CDR0000514506
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Maria R. Baer, MD University of Maryland Greenebaum Cancer Center
Alliance for Clinical Trials in Oncology
July 2015

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