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

Pharmacogenetics of Mylotarg

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01139320
Enrollment
300
Registered
2010-06-08
Start date
2009-09-30
Completion date
Unknown
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

untreated childhood acute myeloid leukemia and other myeloid malignancies

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.

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.

Interventions

GENETICDNA analysis
GENETICpolymerase chain reaction
OTHERlaboratory biomarker analysis
OTHERpharmacological study

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026