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S9031-S9126-S9333-S9500-A, Examination of the Prognostic Significance of AML-Specific and Age-Associated Genes in AML Patients


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

S9031-S9126-S9333-S9500-A, Examination of the Prognostic Significance of AML-Specific and Age-Associated Genes in AML Patients


OBJECTIVES:

- To determine whether the expression of previously identified acute myeloid leukemia
(AML)-specific and age-associated genes have prognostic significance in adult patients
with AML.

- To examine, preliminarily, if AML-specific and age-associated expression changes occur
in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).

- To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG
island/promoter region is correlated with IRF8 gene expression in AML.

OUTLINE: This is a multicenter study.

Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are
obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and
SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and
relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays
and linked to clinical and outcome data from the main SWOG database. Samples from a subset
of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific
and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and
CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with
methylation or histone modification of the IRF8 CPG island/promoter region.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pretreatment RNA specimens* available from patients with acute myeloid leukemia (AML)
registered for front-line therapy on the following clinical trials:

- SWOG-9031

- SWOG-9126

- SWOG-9333

- SWOG-9500

- Cryopreserved pretreatment cell specimens* available from a subset of patients (those
who obtained a complete response [CR] and remained in CR without relapse for ≥ 2
years vs those with resistant disease [i.e., failed to achieve CR with evidence of
persistent AML following induction therapy]) NOTE: All specimens currently available
in the Southwest Oncology Group Myeloid Leukemia and MDS Repository at the University
of New Mexico

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Outcome Measure:

Prognostic significance for complete response, overall survival, and relapse-free survival of total and relative expression levels (variant/wild type ratios) for each gene

Outcome Time Frame:

immediate

Safety Issue:

No

Principal Investigator

Derek L. Stirewalt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000614113

NCT ID:

NCT00899171

Start Date:

November 2008

Completion Date:

September 2012

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • 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 acute erythroid leukemia (M6)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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