Biomarkers in DNA Samples From Younger Patients With Newly Diagnosed Acute Myeloid Leukemia Receiving Gemtuzumab Ozogamicin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 5, 2010
Last updated: June 12, 2010
Last verified: June 2010

RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.

Condition Intervention
Genetic: DNA analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Other: pharmacological study

Study Type: Observational
Official Title: Pharmacogenetics of Mylotarg

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • To analyze candidate-coding polymorphisms in CD33 of DNA samples from children with newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
  • To determine the association between these polymorphisms and clinical response of patients treated with this regimen.

OUTLINE: Archived DNA samples are analyzed for candidate polymorphisms in CD33 by PCR-based sequencing.


Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Newly diagnosed acute myeloid leukemia
  • Treated with gemtuzumab ozogamicin on COG-AAML03P1
  • Genomic DNA samples available


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01139320

Sponsors and Collaborators
Children's Oncology Group
Principal Investigator: Jatinder Lamba, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office Identifier: NCT01139320     History of Changes
Other Study ID Numbers: CDR0000671448, COG-AAML10B3
Study First Received: June 5, 2010
Last Updated: June 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute myeloid leukemia and other myeloid malignancies processed this record on March 26, 2015