Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Childhood Cancer Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk ALL Pilot Project: Application of Array-Based Methods and Gene Re-Sequencing to Identify Candidate Molecular Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00896766
• Other study ID #: AALL06B1
• Secondary ID: COG-AALL06B1CDR0
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 2, 2015
• Start date: July 2006

Study information

• Verified date: November 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk acute lymphoblastic leukemia.

Description:

OBJECTIVES:

• Identify regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts from pediatric patients with high-risk acute lymphoblastic leukemia (ALL) using Affymetrix GeneChip Mapping 500K array sets. (Pilot project)

• Identify regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)

• Define gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays.

• Assess the global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips.

• Utilize array-generated gene expression data and data for CNAs and uniparental disomy to prioritize candidate genes and genomic regions for resequencing.

• Characterize epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)

• Discover candidate therapeutic targets for these patients by identifying genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing. (Pilot project)

• Discover candidate therapeutic targets for these patients by next generation sequencing technologies, including whole genome, whole transcriptome, and whole exome. (Expansion project)

OUTLINE: This is a multicenter study.

Banked biological samples (bone marrow and peripheral blood) are analyzed using gene expression profiling, single-nucleotide polymorphism and genotyping assays, DNA copy number and loss of heterozygosity estimates, epigenetic profiling, and gene resequencing.

PROJECTED ACCRUAL: A total of 150 patient samples will be accrued for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL)

• High-risk disease

• Participation in clinical trial COG-P9906 required (pilot project)

• In complete remission

• Consented to future studies using banked tissue specimens

• Participation in clinical trial and COG-AALL03B1 and linked therapeutic studies COG-AALL0232 and COG- AALL0331(expansion project)

• Experienced a bone marrow relapse within 36 months of initial diagnosis

• Consented to future studies using banked tissue specimens

• Have matched ALL blast and germline specimens

• Demographic, clinical and pathologic data elements for these biospecimens available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• loss of heterozygosity analysis

• microarray analysis

• polymorphism analysis

• tumor replication error analysis

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina

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	Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets			No
Primary	Identification of regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)			No
Primary	Gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays			No
Primary	Global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips			No
Primary	Epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)			No
Primary	Prioritization of candidate genes and genomic regions for resequencing using array-generated gene expression data and data for CNAs			No
Primary	Identification of genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database