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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00482352
First received: June 4, 2007
Last updated: February 13, 2014
Last verified: February 2014

June 4, 2007
February 13, 2014
December 2003
April 2012   (final data collection date for primary outcome measure)
  • Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a classification database for correlative studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a central reference guide for all required and research only ALL studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a leukemia and germline specimen bank for current and future research [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL)
  • Development of a classification database for correlative studies
  • Development of a central reference guide for all required and research only ALL studies
  • Development of a leukemia and germline specimen bank for current and future research
Complete list of historical versions of study NCT00482352 on ClinicalTrials.gov Archive Site
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Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Classification Of Acute Lymphoblastic Leukemia

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

marrow and blood samples

Non-Probability Sample

Any patient with newly diagnosed acute lymphoblastic leukemia meeting other criteria.

  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia
Other: laboratory biomarker analysis
Correlative studies
Ancillary-Correlative (marker identification, molecular test)
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).
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11196
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00482352
AALL03B1, NCI-2009-00303, COG-AALL03B1, CDR0000344369, AALL03B1, AALL03B1, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Mignon Loh, MD Children's Oncology Group
Children's Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP