Title (COG AALL08B1) Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Principal Investigator Martin Brecher, MD
Study Number 182410
Summary The goal of AALL08B1 is to further refine risk stratification algorithms to intensify therapy for patients identified to be at high risk of relapse, while sparing toxicity for those highly likely to be cured. This Children's Oncology group (COG) risk-group classification protocol will provide the foundation for stratification and treatment of patients with newly diagnosed ALL and registration on this protocol is therefore required for entry onto any COG frontline ALL treatment study. Patients will be initially assigned to an induction treatment regimen based on age, white blood count (WBC), the presence of extramedullary disease and immunophenotype. Additional studies performed at local and COG reference laboratories at the time of initial diagnosis and at defined time points during induction will be used to refine pos-induction therapy. Patients with National Cancer Institute (NCI) Standard-Risk (SR) and High-Risk (HR) B-precursor ALL will be distributed among 4 risk groups following induction: Low-Risk (LR), Average Risk (AR), HR and Very High-Risk (VHR). Patients with T-cell ALL, infant ALL and Philadelphia chromosome-positive (Ph+) ALL will be treated on separated therapeutic studies.
- Patient has newly diagnosed acute leukemia: > 25% blasts on a BM aspirate; OR if a VM aspirate is not obtained, the diagnosis of acute leukemia 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 cytogenetic laboratories to allow completion of the studies needed for risk-stratification. (See section 3.2.2)
- Patient must be < 31 years of age a diagnosis of acute leukemia.
- Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies as per Section 4.1 so that the data needed for risk-adjusted post-induction therapy are available. 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.
- Patient must not have received prior cytotoxic therapy except for steroids or intrathecal chemotherapy as defined in Section 3.3.
- Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.