Clinical Trials /

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

NCT01142427

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Active, not recruiting

Trial Eligibility

Document

Title

  • Brief Title: Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
  • Official Title: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Clinical Trial IDs

  • ORG STUDY ID: AALL08B1
  • SECONDARY ID: NCI-2011-02235
  • SECONDARY ID: PAALL08B1_A09PAMDREVW01
  • SECONDARY ID: CDR0000674844
  • SECONDARY ID: COG-AALL08B1
  • SECONDARY ID: AALL08B1
  • SECONDARY ID: AALL08B1
  • SECONDARY ID: U10CA180886
  • SECONDARY ID: U10CA098543
  • NCT ID: NCT01142427

Conditions

  • Adult B Acute Lymphoblastic Leukemia
  • Adult T Acute Lymphoblastic Leukemia
  • Childhood B Acute Lymphoblastic Leukemia
  • Childhood T Acute Lymphoblastic Leukemia
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
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.

    Eligibility Criteria

            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 only PB is submitted,
                      please obtain and send twice the volume of PB as the recommended BM volume
                      specified; the patient will remain on AALL08B1 as long as all required central
                      laboratory tests can be successfully performed; as long as there are at least
                      1,000/uL PB blasts, institutions are encouraged to submit PB in addition to BM
                      samples to make sure that adequate material is available to perform the required
                      studies
    
                   -  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 (there are NO exceptions to this rule)
    
              -  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; if informative results needed for treatment stratification are not
                 available at specified time-points during induction, patients will not be eligible to
                 receive post-induction therapy on a COG ALL trial
    
              -  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
          
    Maximum Eligible Age:30 Years
    Minimum Eligible Age:N/A
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Classification data for correlative studies
    Time Frame:Up to 5 years
    Safety Issue:
    Description:

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Children's Oncology Group

    Last Updated

    February 22, 2018