Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia

Children's Oncology Group

Status: Completed

Conditions: Childhood Acute Erythroleukemia (M6); Childhood Acute Monocytic Leukemia (M5b); Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies; Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Eosinophilic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myelomonocytic Leukemia (M4); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Basophilic Leukemia

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01076569

AAML10B14 (Other Identifier)

U10CA098543 (U.S. NIH Grant/Contract)

COG-AAML10B14 (Other Identifier)

NCI-2011-02212 (Registry Identifier)

Details and patient eligibility

About

This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Full description

PRIMARY OBJECTIVES:

I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).

II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.

III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.

IV. To identify genomic alterations contributing to induction failure in childhood AML.

OUTLINE:

Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.

Enrollment: 250 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of acute myeloid leukemia

  • High-risk disease

• Treated on COG-AAML03P1 or COG-AAML0531

• Meets the following criteria:

  • Initial remission with no known adverse risk factors
  • High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available
  • Highly enriched specimens with >= 50% blast available

Trial design

250 participants in 1 patient group

Ancillary-Correlative (molecular analysis)

Description:

Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome SNP genotyping, expression, and methylation profiling.

Treatment:

Other: laboratory biomarker analysis