Primary Outcome Measures:
- Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL) [ Designated as safety issue: No ]
- Development of a classification database for correlative studies [ Designated as safety issue: No ]
- Development of a central reference guide for all required and research only ALL studies [ Designated as safety issue: No ]
- Development of a leukemia and germline specimen bank for current and future research [ Designated as safety issue: No ]
OBJECTIVES:
- Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (ALL) to a specific treatment clinical trial.
- Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.
- Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories.
- Provide a mechanism for optional banking of leukemia and germline specimens for current and future research.
OUTLINE: Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).
After completion of induction therapy, patients are followed once or twice annually.
PROJECTED ACCRUAL: A total of 7,320 patients (60 infants; 60 patients with very high-risk acute lymphoblastic leukemia [ALL]; 230 patients with T-lineage ALL; 334 patients with low-risk B-precursor ALL; 573 patients with standard-risk B-precursor ALL; and 573 patients with high-risk B-precursor ALL) will be accrued for this study within 4 years.
Purpose
