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

Classification Of Acute Lymphoblastic Leukemia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00482352
Enrollment
11196
Registered
2007-06-05
Start date
2003-12-31
Completion date
2023-06-30
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated Adult Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia

Brief 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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed acute lymphoblastic leukemia, defined by any of the following: * At least 25% blasts in the bone marrow * Absolute blast count at least 10,000/mm\^3, if bone marrow aspiration is not performed * No prior registration on this study

Design outcomes

Primary

MeasureTime frame
Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL)Up to 5 years
Development of a classification database for correlative studiesUp to 5 years
Development of a central reference guide for all required and research only ALL studiesUp to 5 years
Development of a leukemia and germline specimen bank for current and future researchUp to 5 years

Countries

Australia, Canada, New Zealand, Puerto Rico, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026