AALL08B1, Classification of Newly Diagnosed Acute Lymphoblastic Leukemia
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 post-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 separate therapeutic studies. This classification study will also be used for participation in companion biology research studies that are not used for treatment allocation, and for voluntary banking of leukemia cells for future research.
--Patient has newly diagnosed acute leukemia:
> 25% blasts on a 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 COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification.
If a BM aspirate is performed, sample submission guidelines as specified in Section 4.1 should
--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 (ie, 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.
--Patient must be < 31 years of age at diagnosis of acute leukemia.
--Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies so that the data needed for risk-adjusted post-Induction therapy are available.