Intensified Post Remission Therapy Containing PEG-Asparaginase
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic
      leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs
      that are given in different combinations in several steps. Each step of treatment is called a
      cycle. Patients will be treated with the chemotherapy drugs that are routinely used in ALL
      and which are given in multiple treatment cycles over several months. All the chemotherapy
      drugs that are used in this study have been approved by the Food and Drug Administration
      (FDA).

      One of the drugs, which is typically given to patients with ALL, is called Asparaginase. It
      is given together with the other drugs throughout the different cycles of treatment. This
      drug can be derived from several sources. The standard source is called E. coli Asparaginase,
      which is associated with a risk of allergic reactions. This drug stays in the body for a very
      short period of time; therefore, it has to be injected daily for 9-14 days in a cycle of
      treatment.

      In this study, a different form of Asparaginase will be used, called PEG-Asparaginase (also
      called Oncospar), which remains in the body for about two weeks, therefore, it can be given
      only once in a cycle of treatment and still maintains high blood levels of the drug.
      PEG-Asparaginase has recently been approved by the FDA to treat ALL. Most of the experience
      with the drug has been in children with ALL. In children it was found to be as safe as the
      standard form of Asparaginase and with less allergic reaction. It was also found to have the
      same effectiveness on ALL. The experience with this drug in adults has been more limited.

      The purpose of the study is to find out what side effects occur in adults when
      PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the
      response to treatment of ALL. Another purpose is to find out if the allergic reactions are
      reduced with PEG-Asparaginase. In children there is some early information that
      PEG-Asparaginase produces fewer antibodies than E.coli Asparaginase. Therefore, another
      purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop
      antibodies against the drug.
    


Intervention name(s): Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine
Intervention type(s): Drug
Intervention description(s): Induction I/II, consolidation I/II/III/IV and Maintenance
Intervention MeSH terms: Cytarabine; Prednisone; Methotrexate; Cyclophosphamide; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Thioguanine; Pegaspargase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment