CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
Condition: Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: aminopterin; L-asparaginase; cyclophosphamide; cytarabine; daunomycin; dexamethasone; 6-mercaptopurine; methotrexate; 6-thioguanine; vincristine; Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone); Leucovorin
Intervention description: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation; Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
Intervention MeSH terms: Leucovorin; Cytarabine; Dexamethasone; Hydrocortisone; Cyclophosphamide; Methotrexate; Vincristine; Asparaginase; Mercaptopurine; Thioguanine; Daunorubicin; Aminopterin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Acute Lymphocytic Leukemia; Leukemia

Summary:

      The purpose of this research study is to identify better ways to treat children and young
      adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define
      methods to identify those patients at higher risk for certain side effects, as well as those
      who are at higher risk for relapse of their leukemia.
    

Eligibility criteria:

        Inclusion:

          -  Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)

          -  Patients with overt CNS (central nervous system) or testicular disease are eligible

          -  Informed consent according to institutional and FDA guidelines.

          -  Adequate organ function is required.

          -  HIV seropositive patients will not be excluded from this study.

          -  Patients greater than 1 year of age and less than 29.99 years of age are eligible.

        Exclusion Criteria

          -  Patients with medical, psychological, or psychiatric problems that are likely to
             compromise their ability to tolerate intensive therapy will be ineligible.

          -  All patients with evidence of significant organ dysfunction not thought to be
             attributable to ALL (patients with clinically significant congestive heart failure,
             cardiac ejection fraction <40%, total bilirubin >2, serum creatinine >2) will be
             ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those
             patients with history or physical findings suggestive of cardiac dysfunction not
             directly attributable to anemia or ALL. Note: Patients with total bilirubin >2 but
             direct (conjugated) bilirubin less than the upper limit of normal will still be
             eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl
             transferase.