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

Children's Oncology Group

Status: Completed

Conditions: Untreated Childhood Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00482352

CDR0000344369 (Other Identifier)

AALL03B1 (Other Identifier)

U10CA098543 (U.S. NIH Grant/Contract)

COG-AALL03B1 (Other Identifier)

NCI-2009-00303 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,196 patients

Sex: All

Ages: 1 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

11,196 participants in 1 patient group

Ancillary-Correlative (marker identification, molecular test)

Description:

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).

Treatment:

Other: laboratory biomarker analysis