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

Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis

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.

Study Overview

• Status: Completed
• Conditions: Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myelomonocytic Leukemia (M4); Recurrent Childhood Acute Myeloid Leukemia; Childhood Acute Basophilic Leukemia; Childhood Acute Eosinophilic Leukemia; Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
• Intervention / Treatment: Other: laboratory biomarker analysis

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • California
    • Monrovia, California, United States, 91006-3776
      • Children's Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (molecular 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.	Other: laboratory biomarker analysis; Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
LOH status in identifying novel changes associated with pediatric AML	Baseline
Genomic methylation patterns in identifying novel changes associated with pediatric AML	Baseline
Genomic and transcriptome alterations associated with induction failure	Baseline
Genomic alterations contributing to induction failure in childhood AML	Baseline

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Soheil Meshinchi, MD, Children's Oncology Group

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukocyte Disorders; Eosinophilia; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Hypereosinophilic Syndrome; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute
• Other Study ID Numbers: AAML10B14 (Other Identifier: CTEP); U10CA098543 (U.S. NIH Grant/Contract); NCI-2011-02212 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); COG-AAML10B14 (Other Identifier: Children's Oncology Group)