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

Recurrent Childhood Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076569
• Other study ID #: AAML10B14
• Secondary ID: NCI-2011-02212CO
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: May 17, 2016
• Start date: March 2010
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Childhood Acute Basophilic Leukemia
• Childhood Acute Eosinophilic Leukemia
• Childhood Acute Erythroleukemia (M6)
• Childhood Acute Megakaryocytic Leukemia (M7)
• Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
• 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)
• Hypereosinophilic Syndrome
• Leukemia
• Leukemia, Erythroblastic, Acute
• Leukemia, Megakaryoblastic, Acute
• Leukemia, Monocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Recurrent Childhood Acute Myeloid Leukemia
• Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detailed molecular map of pediatric high-risk acute myeloid leukemia		Baseline	No
Primary	Mutations in identifying novel changes associated with pediatric AML		Baseline	No
Primary	Expression profile in identifying novel changes associated with pediatric AML		Baseline	No
Primary	Gene copy number in identifying novel changes associated with pediatric AML		Baseline	No
Primary	LOH status in identifying novel changes associated with pediatric AML		Baseline	No
Primary	Genomic methylation patterns in identifying novel changes associated with pediatric AML		Baseline	No
Primary	Genomic and transcriptome alterations associated with induction failure		Baseline	No
Primary	Genomic alterations contributing to induction failure in childhood AML		Baseline	No