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NCT01139320 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Pharmacogenetics of Mylotarg

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01139320
Other study ID # AAML10B3
Secondary ID COG-AAML10B3CDR0
Status Completed
Phase N/A
First received June 5, 2010
Last updated May 17, 2016
Start date September 2009

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

• pharmacological study

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin No
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