NCT00482352

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

Classification Of Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11,196 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.

Detailed description

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.

Conditions

• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-12-01
• Primary completion: 2012-04-01
• Completion: 2023-06-30
• First posted: 2007-06-05
• Last updated: 2023-08-03

Locations

200 sites across 6 countries: United States, Australia, Canada, New Zealand, Puerto Rico, Switzerland