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

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01139320
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 300

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Pharmacogenetics of Mylotarg
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jatinder Lamba, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01139320
• Other Study ID Numbers: AAML10B3; COG-AAML10B3; CDR0000671448; NCI-2011-02220
• First Posted: Jun 8, 2010
• Last Update Posted: May 18, 2016
• Last Verified: May 1, 2016

• Keywords provided by Children's Oncology Group: untreated childhood acute myeloid leukemia and other myeloid malignancies
• Additional relevant MeSH terms: Leukemia

Study Results

No Results Posted as of May 18, 2016