Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients
N/A
17 Years
Both
Leukemia
Trial Information
Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Ursula R. Kees, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Telethon Institute for Child Health Research
Authority:
United States: Federal Government
Study ID:
CDR0000066224
NCT ID:
NCT00003291
Start Date:
March 1998
Completion Date:
Related Keywords:
- Leukemia
- untreated childhood acute lymphoblastic leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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