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

Children's Oncology Group

Status: Completed

Conditions: Leukemia

Treatments: Genetic: mutation analysis; Other: laboratory biomarker analysis; Genetic: cytogenetic analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00003291

CCG-B969 (Other Identifier)

B969

COG-B969 (Other Identifier)

CDR0000066224 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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