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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01407757
First received: July 30, 2011
Last updated: August 6, 2011
Last verified: August 2011

July 30, 2011
August 6, 2011
July 2011
September 2011   (final data collection date for primary outcome measure)
Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy [ Designated as safety issue: No ]
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.

OBJECTIVES:

  • 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
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Leukemia
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Other: laboratory biomarker analysis
  • Other: pharmacogenomic studies
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
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September 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
up to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01407757
CDR0000706823, COG-AAML11B10
Not Provided
Peter C. Adamson, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jatinder Lamba, MD Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP