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Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia

Genetic Predictors of AML Treatment Response

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01024127
Enrollment
2500
Registered
2009-12-02
Start date
2009-12-31
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

Adult Acute Myeloid Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission

Brief summary

This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

Detailed description

PRIMARY OBJECTIVES: l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk. II. Validate positive associations seen in the genome-wide scan with a fine mapping approach. III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML. OUTLINE: Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of AML * In remission * Adequate DNA from peripheral blood or bone marrow samples * Concurrent enrollment on CCG-2961, COG-AAML03P1, COG-AAML0531, AML-93, AML-97, AML-04,AML-09, or Canada AML Infection clinical trial required

Design outcomes

Primary

MeasureTime frame
Incidence of first acute myeloid leukemia relapseUp to 2 years
Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at riskFrom study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years

Countries

United States

Outcome results

None listed

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