The Development of Predictive Biomarker Models for Patients Receiving Standard Induction Chemotherapy With and Without Gemtuzumab Ozogamicin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 365
- Primary Endpoint
- Development of risk-assessment biomarker model for clinical outcomes
Study Overview
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 Design
- Study Type
- Observational
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 88 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Development of risk-assessment biomarker model for clinical outcomes
Time Frame: 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
Time Frame: immediate
Secondary Outcomes
No secondary outcomes reported