Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
RATIONALE: Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.
Genetic: DNA ploidy analysis
Genetic: chromosomal translocation analysis
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: cytology specimen collection procedure
Other: flow cytometry
Other: laboratory biomarker analysis
|Official Title:||Classification of Newly Diagnosed Acute Lymphoblastic Leukemia|
- Development of a risk-based classification system to be used to assign patients newly diagnosed with acute lymphoblastic leukemia (ALL) to frontline specific-treatment studies [ Designated as safety issue: No ]
- Development of a classification data for correlative studies [ Designated as safety issue: No ]
- Development of a central reference guide for required and research ALL studies [ Designated as safety issue: No ]
- Development of leukemia and germline specimens for current and future research [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
- 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.