Clinical Trial COGAALL0932
Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
- Protocol No. COGAALL0932
- Open Date: 11/11/2010
- Staging: Phase III
- Age Group: Children
- Scope: National
- Objective: 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. 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. 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 methotrexate without alkylating agents or anthracyclines, or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during Maintenance. 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.
- Disease Sites: Pediatrics; Leukemia
- Therapies: Chemotherapy - cytotoxic; Therapy (NOS)
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- Secondary Protocol No: AALL0932
Not provided. Please call for more information.