Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

OBJECTIVES:

I. 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.

II. Provide an administrative base to capture classification data for correlative studies
accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.

III. Provide a central reference guide for all required and research only ALL studies that
will be conducted at local and reference laboratories.

IV. 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.

Inclusion Criteria:

- Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:

- At least 25% blasts in the bone marrow

- Absolute blast count at least 10,000/mm^3, if bone marrow aspiration is not
performed

- No prior registration on this study