Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01142427
First received: June 10, 2010
Last updated: February 12, 2014
Last verified: February 2014

June 10, 2010
February 12, 2014
August 2010
January 2100   (final data collection date for primary outcome measure)
  • Development of a risk-based classification system to be used to assign patients with newly diagnosed ALL to frontline specific-treatment studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a classification data for correlative studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a central reference guide for required and research ALL studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of leukemia and germline specimens for current and future research [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a risk-based classification system to be used to assign patients newly diagnosed with acute lymphoblastic leukemia (ALL) to frontline specific-treatment studies [ Designated as safety issue: No ]
  • Development of a classification data for correlative studies [ Designated as safety issue: No ]
  • Development of a central reference guide for required and research ALL studies [ Designated as safety issue: No ]
  • Development of leukemia and germline specimens for current and future research [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01142427 on ClinicalTrials.gov Archive Site
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Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PRIMARY OBJECTIVES:

I. To provide a risk-based classification system based on clinical, pathological, molecular, and early response data that will be used to assign all patients with newly diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG) frontline specific-treatment studies.

II. To capture classification data for correlative studies accompanying current COG ALL treatment protocols.

III. To provide a central reference guide for all required and research studies that will be conducted in local and reference laboratories for all newly diagnosed ALL patients.

IV. To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (B-cell precursor vs infant vs T-cell acute lymphoblastic leukemia [ALL]).

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in situ hybridization (FISH). Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments. Some samples (leukemic and germline) may be banked for current and/or future analyses.

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

Bone Marrow Sample Blood Sample

Non-Probability Sample

Newly diagnosed acute leukemia

  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia
Other: laboratory biomarker analysis
Correlative studies
Health research services (classification)

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, DNA ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and FISH. Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments.

Some samples (leukemic and germline) may be banked for current and/or future analyses.

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.
 
Recruiting
11500
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed acute leukemia meeting 1 of the following criteria:

    • > 25% blasts by bone marrow (BM) aspirate
    • If a BM aspirate is not obtained, the diagnosis of acute leukemia can be established by a pathologic diagnosis of acute leukemia on a BM biopsy
    • A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic blasts
  • Adequate samples must be provided to the reference and/or Children's Oncology Group (COG)-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification
  • Patients with suspected acute lymphoblastic leukemia (ALL) who have true biphenotypic or bilineage leukemia (i.e., patient with significant blasts expression of multiple lymphoid and myeloid markers that cannot be assignment to a single lineage) are allowed to enroll in AALL08B1 cell banking

    • No patients with blast-myeloid morphology or whose blasts are myeloperoxidase positive
  • Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patient must not have received prior cytotoxic therapy except for steroids or intrathecal chemotherapy
  • Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
Both
up to 30 Years
No
United States,   Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland
 
NCT01142427
AALL08B1, NCI-2011-02235, CDR0000674844, COG-AALL08B1, AALL08B1, AALL08B1, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Karen Rabin, 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