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Clinical Trial COGAALL0932


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)

Howard Katzenstein


  • 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


None Provided.


Ages Eligible for Study:1 Year to 30 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0932
• Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stages I or II; patients with Down syndrome are also eligible
• Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
• Meets the criteria for one of the following risk groups after induction therapy
• Low-risk (LR) disease, defined as meeting the following criteria:
• Favorable genetics: the presence of simultaneous trisomies of chromosome 4 and 10 (double trisomy; DT) or ETV6/RUNX1 fusion
• Day 8 peripheral blood (PB) minimal residual disease (MRD) < 0.01%
• Day 29 bone marrow (BM) MRD < 0.01%
• No CNS2*, CNS3*, or testicular† leukemia
• No steroid pretreatment
• No Down syndrome (DS)
• Average-risk disease, defined as meeting one of the following sets of criteria:
• Favorable genetics: the presence of DT or ETV6/RUNX1 fusions
• Day 8 PB MRD ≥ 0.01% or CNS2* status
• Day 29 BM MRD < 0.01%
• No CNS3* or testicular† leukemia
• No DS
• Neither favorable nor unfavorable cytogenetics‡
• Day 8 PB MRD < 1%
• Day 29 BM MRD < 0.01%
• No CNS3* or testicular† leukemia
• No DS
• Standard-risk with Down syndrome (DS), defined as meeting the following criteria:
• No mixed-lineage leukemia (MLL)-rearrangement, hypodiploidy**, or Philadelphia chromosome-positive (Ph+) disease††
• Day 29 BM MRD < 0.01%‡‡
• No CNS3* or testicular† leukemia
• WBC count < 50,000/mm^3
• No prior cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously
• Steroids* and intrathecal cytarabine for the current diagnosis of ALL allowed
• Inhalational steroids are not considered as pretreatment
• Patients with testicular leukemia are not eligible for AALL0932