Clinical Trials

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

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

- 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.

- Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.

- Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories.

- 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.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age

- Under 31

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Last updated: 03/26/2012

NCT ID:

NCT00482352