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Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)


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

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Trial Information

Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Outcome Measure:

Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms

Outcome Time Frame:

immediate

Safety Issue:

No

Principal Investigator

Anjali Advani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000664320

NCT ID:

NCT01059734

Start Date:

June 2010

Completion Date:

June 2013

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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