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Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531

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ClinicalTrials.gov Identifier: NCT01407757
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : May 19, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

July 30, 2011
August 2, 2011
May 19, 2016
July 2011
May 2016   (Final data collection date for primary outcome measure)
Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy
Same as current
Complete list of historical versions of study NCT01407757 on ClinicalTrials.gov Archive Site
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Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531
Pharmacogenetics of Gemtuzumab Ozogamicin (GO) Therapy in Acute Myeloid Leukemia

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.


  • 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.

Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample
Diagnosed with acute myeloid leukemia.
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Other: laboratory biomarker analysis
  • Other: pharmacogenomic studies
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Vujkovic M, Attiyeh EF, Ries RE, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Wang YC, Gerbing RB, Sung L, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Genomic architecture and treatment outcome in pediatric acute myeloid leukemia: a Children's Oncology Group report. Blood. 2017 Jun 8;129(23):3051-3058. doi: 10.1182/blood-2017-03-772384. Epub 2017 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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May 2016   (Final data collection date for primary outcome measure)


  • Diagnosed with acute myeloid leukemia
  • DNA samples from patients treated on COG-AAML0531


  • Not specified


  • See Disease Characteristics
Sexes Eligible for Study: All
up to 29 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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COG-AAML11B10 ( Other Identifier: Children's Oncology Group )
AAML11B10 ( Other Identifier: Children's Oncology Group )
NCI-2011-03802 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
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Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jatinder Lamba, MD Masonic Cancer Center, University of Minnesota
Children's Oncology Group
May 2016