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Multidrug Resistance Protein Gene Polymorphisms in Acute Myeloid Leukemia. A CALGB Leukemia Tissue Bank Project


N/A
15 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Multidrug Resistance Protein Gene Polymorphisms in Acute Myeloid Leukemia. A CALGB Leukemia Tissue Bank Project


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Maria R. Baer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

Unspecified

Study ID:

CDR0000514506

NCT ID:

NCT00898456

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • 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)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute basophilic leukemia
  • adult acute eosinophilic leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815