Treatment of Patients with Newly Diagnosed Standard Risk Lymphoblastic Leukemia (B-ALL) or localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Participants in this study have newly diagnosed B-lymphoblastic leukemia (B-ALL) or B-lymphoblastic lymphoma (B-LLy). Patients with Down Syndrome are eligible.
The purpose of this study is to :
1. To determine if a Maintenance regimen containing weekly oral methotrexate at 40 mg/m²/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m²/week in the AR subset of patients with Standard Risk B-precursor ALL.
2. To determine whether a reduced-pulses Maintenance regimen with vincristine/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with Standard Risk B-precursor ALL.
3. To confirm that patients in the LR subset of Standard Risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5-year DFS of at least 95% with either a P9904-based regimen that includes 6 courses of intermediate dose (1 g/m2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during Maintenance (Arm LR-C).
4. To provide standardized treatment and enhanced supportive care to children with SR DS-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup.
5. To improve understanding of the biology of localized B-LLy and DS b-LLy by obtaining biologic data, Including FISH for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research.
6. To describe the 5-year EFS and overall survi