CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
Condition: Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Outline of Therapy:

      Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally
      (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half
      years.

      Therapy will be divided into five phases:

      Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal
      blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia
      cells in the bone marrow).

      Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed
      Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia
      cells will be given only for patients at high risk of relapse.

      Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight
      times.

      Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with
      one clinic visit for a lumbar puncture every eight weeks.

      Irradiation: radiation will be given in the middle of intensive continuation to the head and
      spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time
      of diagnosis.

      Follow-up: After the conclusion of therapy, there will be periodic office visits, initially
      monthly, then gradually spaced out to annual visits. The purpose of these visits is to
      evaluate for late side-effects of therapy.
    

Intervention name(s): aminopterin; L-asparaginase; cyclophosphamide; cytarabine; daunomycin; dexamethasone; 6-mercaptopurine; methotrexate; 6-thioguanine; vincristine; Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone); Leucovorin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphocytic Leukemia; Leukemia