Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003291
• Other study ID #: B969
• Secondary ID: COG-B969CCG-B969
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: August 7, 2014
• Start date: March 1998

Study information

• Verified date: August 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.

Description:

OBJECTIVES:

• Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.

• Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.

OUTLINE: Patients are stratified by risk (standard vs high).

Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Patients are followed for at least 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

DISEASE CHARACTERISTICS:

• Newly diagnosed acute lymphoblastic leukemia (ALL)

• Meets criteria for 1 of the following:

• Standard risk, as defined by the following:

• 1 to 10 years old at diagnosis

• WBC less than 50,000/mm^3

• High risk, as defined by the following:

• Less than 1 year old or over 10 years old at diagnosis

• WBC greater than 50,000/mm^3

• Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• 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:
• cytogenetic analysis

• mutation analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
Australia	Princess Margaret Hospital for Children	Perth	Western Australia

Sponsors (2)

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

Country where clinical trial is conducted

Australia,