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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139320
First Posted: June 8, 2010
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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
Leukemia 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

Estimated Enrollment: 300
Study Start Date: September 2009
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139320


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01139320     History of Changes
Other Study ID Numbers: AAML10B3
COG-AAML10B3 ( Other Identifier: Children's Oncology Group )
CDR0000671448 ( Other Identifier: Clinical Trials.gov )
NCI-2011-02220 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 5, 2010
First Posted: June 8, 2010
Last Update Posted: May 18, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Gemtuzumab
Antineoplastic Agents