Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01653613
• Other study ID #: ECOG-E2L10T1
• Secondary ID: CDR0000737435
• Status: Not yet recruiting
• Phase: N/A
• First received: July 27, 2012
• Last updated: July 9, 2013
• Start date: August 2010

Study information

• Verified date: July 2012
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• 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. It may also help doctors find better ways to treat cancer.

PURPOSE: This laboratory study is looking into genes in samples from younger patients with acute lymphoblastic leukemia (ALL).

Description:

OBJECTIVES:

• To identify somatically acquired genetic copy number and sequence alterations at the time of diagnosis in adolescent and young adults (AYA) acute lymphoblastic leukemia (ALL) samples and to correlate them with clinical and laboratory characteristics and outcome.

• To identify specific microarray multi-gene and multi-exon expression signatures at the time of diagnosis and to correlate them with clinical and laboratory characteristics and outcome.

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

OUTLINE: Cryopreserved samples are analyzed for DNA copy number alterations and loss-of-heterozygosity, gene expression profiling, and mutation analysis by single nucleotide polymorphism (SNP) microarrays, Affymetrix Exon arrays, and whole genome amplification (WGA, Repli-G Qiagen). Confirmation studies are then done by fluorescence in situ hybridization (FISH), reverse transcriptase (RT)-polymerase chain reaction (PCR), and rapid amplification of cDNA ends (RACE).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 39 Years

Eligibility

DISEASE CHARACTERISTICS:

• Samples from patients diagnosed with B-progenitor AYA ALL from:

• The Children's Oncology Group high risk ALL Study AALL0232 (age 16-21)

• The St. Jude Children's Research Hospital (SJCRH) Total XV studies (age 16-21)

• AYA ALL (from patients 22-30 years of age and from patients age 31-39 years) existing in the ALL Tissue Repositories of the adult National Cancer Institute (NCI) Cooperative Oncology Groups

• The Cancer and Leukemia Group B (CALGB)

• The Eastern Cooperative Oncology Group (ECOG)

• The Southwest Oncology Group (SWOG)

• Cryopreserved viable leukemic cell suspensions, obtained from bone marrow or peripheral blood at pretreatment and initial diagnosis

• Matched normal (germline) samples from end induction-remission bone marrow or blood samples or from buccal swabs, if available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

N/A

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

• polymorphism analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of somatically acquired genetic copy number and sequence alterations			No
Primary	Associations between genetic lesions (including mutations and copy number alterations) and known prognostic factors such as age group and white blood count at the time of diagnosis group using a Fisher exact test or Chi squared			No
Primary	Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion			No

External Links

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