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

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ClinicalTrials.gov Identifier: NCT01139320
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment
Leukemia Genetic: DNA analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study

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.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenetics of Mylotarg
Study Start Date : September 2009
Actual Primary Completion Date : May 2016





Primary Outcome Measures :
  1. Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin


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

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

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 Posted: June 8, 2010    Key Record Dates
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