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Clinical Trial COGAALL08B1

Title

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Principal Investigator(s)

Haydar Frangoul

Details

  • Protocol No. COGAALL08B1
  • Open Date: 10/18/2010
  • Staging: N/A
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: To provide a risk classification scheme for all patients with newly diagnosed ALL, which will be used to assign treatment on Children's Oncology Group (COG) frontline ALL treatment studies. To capture classification data for correlative studies accompanying current COG ALL treatment protocols. 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 patients with ALL. To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.
  • Disease Sites: Pediatrics; Leukemia
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01142427
  • Secondary Protocol No: AALL08B1

Description

None Provided.

Eligibility

Ages Eligible for Study:N/A to 30 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

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