Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
PRIMARY OBJECTIVES:
I. To provide a risk classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children?s Oncology Group (COG) frontline ALL treatment studies.
II. To capture classification data for correlative studies accompanying current COG ALL treatment protocols.
III. 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.
IV. To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.
OUTLINE:
Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in situ hybridization (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.
Inclusion Criteria:
Patient has newly diagnosed acute leukemia:
Adequate samples must be provided to the reference and/or COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification
Patient has suspected ALL:
Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies; if informative results needed for treatment stratification are not available at specified time-points during induction, patients will not be eligible to receive post-induction therapy on a COG ALL trial
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
Sacramento, California 95817, United States
Torrance, California 90502, United States
Denver, Colorado 80218, United States
Miami, Florida 33136, United States
Minneapolis, Minnesota 55404, United States
New Brunswick, New Jersey 08903, United States
New Hyde Park, New York 11040, United States
Houston, Texas 77030, United States
Spokane, Washington 99204, United States
Hunter Regional Mail Centre, New South Wales 2310, Australia