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

Completed

• Conditions: Childhood Acute Monocytic Leukemia (M5b); Recurrent Childhood Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies; Childhood Acute Basophilic Leukemia; Childhood Acute Erythroleukemia (M6); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Eosinophilic Leukemia; Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01076569
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Start: 2010-03
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (molecular analysis)	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Detailed molecular map of pediatric high-risk acute myeloid leukemia	Baseline
Mutations in identifying novel changes associated with pediatric AML	Baseline
Expression profile in identifying novel changes associated with pediatric AML	Baseline
Gene copy number in identifying novel changes associated with pediatric AML	Baseline
Genomic methylation patterns in identifying novel changes associated with pediatric AML	Baseline
Genomic alterations contributing to induction failure in childhood AML	Baseline
LOH status in identifying novel changes associated with pediatric AML	Baseline
Genomic and transcriptome alterations associated with induction failure	Baseline

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States