COG-AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) A Groupwide Phase III Study

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COG-AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) A Groupwide Phase III Study

1.To determine if a Maintenance regimen containing weekly oral methotrexate at 40 mg/m2/week will result in an improved disease free survival compared to that containing weekly oral methotrexate at 20 mg/m2/week in the average risk 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 average risk subset of patients with Standard Risk B-precursor ALL.
3.To confirm that patients in the low risk 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 or an outpatient based regimen identical to that of average risk patients with vincristine/dexamethasone pulses at 12 week intervals during maintenance

Protocol Number111007
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesLeukemia, not otherwise specified
Participating InstitutionsRutgers Cancer Institute of New Jersey
Robert Wood Johnson Medical School
Robert Wood Johnson University Hospital in New Brunswick

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.