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

Completed

• Conditions: Leukemia

• Registration Number: NCT01503541
• Lead Sponsor: SWOG Cancer Research Network

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-01
• Study First Submitted QC: 2012-01-01
• Study First Posted: 2012-01-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-01
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of risk-assessment biomarker model for clinical outcomes	immediate
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