S9031-9333-0106-0112-A Study of Biomarkers in Samples From Patients With Acute Myeloid Leukemia Treated With Standard Chemotherapy With or Without Gemtuzumab Ozogamicin

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503541
• Other study ID #: S9031-9333-0106-0112-A
• Secondary ID: S9031-9333-0106-
• Status: Completed
• Phase: N/A
• First received: January 1, 2012
• Last updated: March 5, 2015
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2014
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• DNA analysis

• RNA analysis

• gene expression analysis

• mutation analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker assays in highly purified populations of AML myeloblasts are more predictive of clinical outcomes as compared to the same tests examining unsorted cells		immediate	No
Primary	Development of risk-assessment biomarker model for clinical outcomes		immediate	No