Trial Information

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia

OBJECTIVES:

- To provide a risk-based classification system based on clinical, pathological,
molecular, and early response data that will be used to assign all patients with newly
diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG)
frontline specific-treatment studies.

- To capture classification data for correlative studies accompanying current COG ALL
treatment protocols.

- To provide a central reference guide for all required and research studies that will be
conducted in local and reference laboratories for all newly diagnosed ALL patients.

- To provide a mechanism for optional banking of leukemia and germline specimens for
current and future research.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (B-cell
precursor vs infant vs T-cell acute lymphoblastic leukemia [ALL]).

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and
after induction therapy for immunophenotyping for ALL confirmation and classification, DNA
ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing
for translocations) analysis by flow cytometry and FISH. Immunophenotype results obtained on
this study are used to determine patient's assignment to specific clinical-trial treatments.

Some samples (leukemic and germline) may be banked for current and/or future analyses.