Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284010
• Other study ID #: CALGB-21001
• Secondary ID: CALGB-21001RC1CA
• Status: Completed
• Start date: February 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2020
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

PURPOSE: This research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.

Description:

OBJECTIVES:

• To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis.

• To perform candidate gene resequencing of diagnostic ALL samples.

• To examine correlation of genetic alterations with outcome.

• To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome.

• To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL.

OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion:

• Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)

Related Conditions & MeSH terms

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

Intervention

Genetic:
• DNA analysis

• fluorescence in situ hybridization

• gene expression analysis

• microarray analysis

• mutation analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate		Up to 7 Years
Primary	disease free survival		Up to 7 Years
Primary	cumulative incidence of relapse		Up to 7 years
Primary	overall survival		Up to 7 years
Primary	event-free survival		Up to 7 years