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Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2010
First Received: June 4, 2007   Last Updated: February 6, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00482352
  Purpose

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.


Condition Intervention
Leukemia
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 Type: Observational
Official Title: Classification Of Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment: 10500
Study Start Date: January 2004
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482352

  Show 204 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Mignon Loh, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Carroll AJ, Heerema NA, Gastier-Foster JM, et al.: Masked hypodiploidy: hypodiploid acute lymphoblastic leukemia (ALL) in children mimicking hyperdiploid ALL: A report from the Children's Oncology Group (COG) AALL03B1 study. [Abstract] Blood 114 (22): A-1580, 2009.
Loh ML, Raetz E, Devidas M, et al.: Early response to therapy is significantly associated with genetic subtype of acute lymphoblastic leukemia: a report from the Children's Oncology Group. [Abstract] Blood 110 (11): A-758, 2007.

Study ID Numbers: CDR0000344369, COG-AALL03B1
Study First Received: June 4, 2007
Last Updated: February 6, 2010
ClinicalTrials.gov Identifier: NCT00482352     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 08, 2010