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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: June 5, 2010
Last updated: May 6, 2015
Last verified: May 2015

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
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenetics of Mylotarg

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

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: January 2100 (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
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.


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


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01139320

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

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group Identifier: NCT01139320     History of Changes
Other Study ID Numbers: AAML10B3, COG-AAML10B3, CDR0000671448, NCI-2011-02220
Study First Received: June 5, 2010
Last Updated: May 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
untreated childhood acute myeloid leukemia and other myeloid malignancies

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type processed this record on November 25, 2015