NCT01142427

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

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17,463 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2010-08-09
• Primary completion: 2015-05-01
• Completion: 2023-09-30
• First posted: 2010-06-11
• Last updated: 2023-10-03

Locations

244 sites across 7 countries: United States, Australia, Canada, Ireland, New Zealand, Puerto Rico, Switzerland