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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 9, 2014
Last verified: September 2014

June 10, 2010
September 9, 2014
August 2010
January 2100   (final data collection date for primary outcome measure)
  • Development of a risk classification system to be used to assign patients to treatment on COG frontline ALL treatment studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • 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 mechanism for optional 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 trial studies 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 classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children's Oncology Group (COG) frontline ALL 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:

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 Blood

Non-Probability Sample

Newly diagnosed acute leukemia

  • B-cell Adult Acute Lymphoblastic Leukemia
  • B-cell Childhood Acute Lymphoblastic Leukemia
  • T-cell Adult Acute Lymphoblastic Leukemia
  • T-cell Childhood Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: cytology specimen collection procedure
    Correlative studies
    Other Name: cytologic sampling
Ancillary-Correlative (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.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: cytology specimen collection procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
11750
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has newly diagnosed acute leukemia:

    • > 25% blasts on a bone marrow (BM) aspirate or
    • If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy or
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic blasts
  • Adequate samples must be provided to the reference and/or COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification

    • If a BM aspirate is not performed, or adequate material cannot be obtained, peripheral blood (PB) can be substituted for BM if there are at least 1,000 circulating blasts/uL (i.e., a white blood cell [WBC] count of 10,000/uL with 10% blasts or a WBC count of 5,000/uL with 20% blasts)
    • If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL clinical trial
  • Patient has suspected ALL:

    • Patients whose blast morphology is obviously myeloid, or whose blasts are myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts with significant expression of multiple lymphoid and myeloid markers such that assignment to a single lineage is not possible) are eligible to enroll in AALL08B1 for cell banking
  • 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,   Ireland,   New Zealand,   Puerto Rico,   Switzerland
 
NCT01142427
AALL08B1, NCI-2011-02235, CDR0000674844, COG-AALL08B1, AALL08B1, AALL08B1, U10CA180886, U10CA098543
Not Provided
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
September 2014

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