Clinical Trial COGAALL0932

Title

Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

Principal Investigator(s)

Haydar Frangoul

Details

  • 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
  • National Clinical Trial ID: NCT01190930
  • Secondary Protocol No: AALL0932

Description

Eligibility

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