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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 4, 2007

Last Updated Date

May 12, 2009

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL) [ Designated as safety issue: No ]
Development of a classification database for correlative studies [ Designated as safety issue: No ]
Development of a central reference guide for all required and research only ALL studies [ Designated as safety issue: No ]
Development of a leukemia and germline specimen bank for current and future research [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00482352 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Classification Of Acute Lymphoblastic Leukemia

Brief Summary

RATIONALE: Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.

PURPOSE: This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia.

Detailed Description

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Condition ^†

Leukemia

Intervention ^†

Genetic: DNA ploidy analysis
Genetic: chromosomal translocation analysis
Genetic: fluorescence in situ hybridization
Genetic: polymorphism analysis
Other: immunologic technique
Other: laboratory biomarker analysis
Procedure: biopsy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

10500

Completion Date

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

1 Year to 30 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada, New Zealand, Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00482352

Responsible Party

Secondary IDs ^††

COG-AALL03B1

Study Sponsor ^†

Children's Oncology Group

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Mignon Loh, MD

UCSF Helen Diller Family Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.