Risk-Based Classification System of Pts W/Newly Diagnosed ALL

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia.

November 22, 2017

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica

    Trial Phone: 321.841.3837

  • IRB No: AALL08B1

    Principal Investigator: Vincent F. Giusti, MD

    Sub Investigators: AguilarBonilla, Ana MD; Eslin, Don MD; Pope, Michele ARNP; Smith, Amy MD; Story, Allison ARNP; Sullivan, Kelly ARNP; Sutphin, Robert MD; Wieber, Laura ARNP; Levy, Alejandro MD

    Age Group: Pediatric

    Secondary Protocol No: AALL08B1

    Treatment: Procedural

    Applicable Disease Sites: Leukemia

    Therapies Involved: Other: laboratory biomarker analysis Other: cytology specimen collection procedure

    ClinicalTrials.gov ID: NCT01142427

  • Objective

    Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

  • Key Eligibility

    Eligibility

    Ages Eligible for Study: up to 30 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No
    Sampling Method: Non-Probability Sample

    Study Population

    Patients with newly diagnosed ALL treated at COG

    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