Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Completed	Children	NCI	COG-B969 CCG-B969, NCT00003291

Objectives

1. Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
2. 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



• 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

A 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 Contact Information

Trial Lead Organizations

Children's Oncology Group

Ursula Kees, PhD, Protocol chair		Ph: 61-8-9489-7852

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		2004-02-11
NCI Grant/Contract Number		CA97452

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