Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Diagnostic | Completed | Children | NCI | COG-B969 CCG-B969, NCT00003291 |
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.
Entry 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/mm3
- High risk, as defined by the following:
- Less than 1 year old or over 10 years old at diagnosis
- WBC greater than 50,000/mm3
- Standard risk, as defined by the following:
- Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)
Prior/Concurrent Therapy:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Patient Characteristics:
Age:
- See Disease Characteristics
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Expected Enrollment
200A total of 200 patients will be accrued for this study.
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.
Trial Lead Organizations
Children's Oncology Group
 | | | |
| Ursula Kees, PhD, Protocol chair | |
| |
| |||
Related Information
PDQ® clinical trial CCG-1922
PDQ® clinical trial CCG-1882
PDQ® clinical trial CCG-1901
| Registry Information | ||
| ||
| Official Title | Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients | |
| ||
| Trial Start Date | 1998-03-03 | |
| ||
| Registered in ClinicalTrials.gov | NCT00003291 | |
| ||
| Date Submitted to PDQ | 1998-09-15 | |
| ||
| Information Last Verified | 2010-11-12 | |
| ||
| NCI Grant/Contract Number | CA97452 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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