Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia
NCT ID: NCT00898456
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
600 participants
OBSERVATIONAL
2006-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
gene expression analysis
molecular genetic technique
polymorphism analysis
protein expression analysis
diagnostic laboratory biomarker analysis
Interventions
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gene expression analysis
molecular genetic technique
polymorphism analysis
protein expression analysis
diagnostic laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Maria R. Baer, MD
Role: STUDY_CHAIR
University of Maryland Greenebaum Cancer Center
Locations
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Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Countries
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Other Identifiers
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CALGB-20501
Identifier Type: -
Identifier Source: secondary_id
CDR0000514506
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-20501
Identifier Type: -
Identifier Source: org_study_id
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