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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02202 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000660540 | Other Identifier | Clinical Trials.gov | |
| COG-AAML10B11 | Other Identifier | Children's Oncology Group | |
| AAML10B11 | Other Identifier | Children's Oncology Group | |
| AAML10B11 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-correlative (predictors of AML treatment outcomes) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of first acute myeloid leukemia relapse | Up to 2 years | |
| Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at risk | From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years |
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Inclusion Criteria:
Diagnosis of AML
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
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Diagnosis of AML in remission
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| Name | Affiliation | Role |
|---|---|---|
| Richard Aplenc, MD | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Philadelphia | Pennsylvania | 19104 | United States |
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blood and bone marrow