Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531
RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.
PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.
Genetic: DNA analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Pharmacogenetics of Gemtuzumab Ozogamicin (GO) Therapy in Acute Myeloid Leukemia|
- Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).
OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407757
|Principal Investigator:||Jatinder Lamba, MD||Masonic Cancer Center, University of Minnesota|