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The Development of Predictive Biomarker Models for Patients Receiving Standard Induction Chemotherapy With and Without Gemtuzumab Ozogamicin


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

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Trial Information

The Development of Predictive Biomarker Models for Patients Receiving Standard Induction Chemotherapy With and Without Gemtuzumab Ozogamicin


OBJECTIVES:

- To determine whether measuring biomarkers in less-differentiated acute myeloid leukemia
(AML) blasts significantly improves their predictive accuracy to predict clinical
outcomes for patients receiving induction/consolidation chemotherapy with and without
gemtuzumab ozogamicin.

- To develop and validate novel predictive biomarker models for predicting clinical
outcomes for AML patients receiving induction/consolidation chemotherapy with and
without gemtuzumab ozogamicin.

OUTLINE: DNA and RNA extracted from archived bone marrow and peripheral blood samples are
analyzed for genomic mutations (CEBPA, FLT3, IDH1/2, KIT, NPM1, RUNX1, TP53, and WT1) and
transcriptional biomarkers (BAALC, CCNA1, CD34, CEBPA, ERG, EVI1, FLT3, IL3RA, MCL1 [two
splice variants], MN1, RUNX1, and WT1) by PCR and real-time PCR. Data are then analyzed by
the Gene Scan software.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pretreatment bone marrow (BM) and peripheral blood (PB) samples obtained from
Southwest Oncology Group ( SWOG) Leukemia Repository for adult patients enrolled on
SWOG-9031, SWOG-9333, SWOG-S0106, and SWOG-S0112

- Samples restricted to those patients from these studies with at least 3 or more vials
of remaining material in the SWOG Leukemia Repository and vials containing at least
1.5 x 10^7 cells/vial

- Samples from patients who received standard induction with cytarabine
(ARA)/daunorubicin hydrochloride (DNR) with the addition of gemtuzumab ozogamicin
(Mylotarg®) on one arm of S0106

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Outcome Measure:

Biomarker assays in highly purified populations of AML myeloblasts are more predictive of clinical outcomes as compared to the same tests examining unsorted cells

Outcome Time Frame:

immediate

Safety Issue:

No

Principal Investigator

Derek L. Stirewalt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000721439

NCT ID:

NCT01503541

Start Date:

December 2011

Completion Date:

June 2014

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(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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