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Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531

C

Children's Oncology Group

Status

Completed

Conditions

Leukemia

Treatments

Other: pharmacogenomic studies
Other: laboratory biomarker analysis
Genetic: gene expression analysis
Genetic: DNA analysis

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01407757
COG-AAML11B10 (Other Identifier)
NCI-2011-03802 (Registry Identifier)
AAML11B10 (Other Identifier)

Details and patient eligibility

About

RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.

PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.

Full description

OBJECTIVES:

  • To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).

OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.

Enrollment

1,000 estimated patients

Sex

All

Ages

Under 29 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with acute myeloid leukemia
  • DNA samples from patients treated on COG-AAML0531

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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