Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Official Title

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Summary:

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.

Trial Description

Primary Outcome:

  • Classification data for correlative studies
  • Development of a central reference guide for required and research ALL studies
  • Development of a risk classification system to be used to assign patients to treatment on COG frontline ALL treatment studies
  • Development of mechanism for optional leukemia and germline specimens for current and future research
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society