Clinical Trial: Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Nega

Brief Summary: The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when used alone and together with chemotherapy and find out what effects, if any, it has on people.

Detailed Summary:

The study consists of three treatment phases.

  1. Steroid prophase (days -3 to -1):

    To prevent rapid leukemia progression and reduce tumor load, patients will receive either prednisone 60mg/m2 oral daily or equivalent corticosteroid daily for 3 days.

  2. Asparaginase phase (days 1 - 14):

    Patients will receive Erwinia asparaginase 25,000 IU/m2 IV three times a week on a Monday, Wednesday, Friday (MWF) schedule for 2 weeks. Patients are permitted to begin Erwinia asparaginase on Monday, Wednesday, or Friday, so that their schedules are defined as MWF, WFM, or FMW. For rapid progression of disease (defined by rising WBC >30K with > 50% peripheral blasts), prednisone 60mg/m2 oral daily or equivalent corticosteroid daily may be added.

    Bone marrow aspirate and/or biopsy will be performed on days 13-15 of the asparaginase treatment for early disease response assessment.

  3. Chemotherapy phase (days 15 - 42):

    • Cyclophosphamide 650 mg/m2 IV on day 15
    • Vincristine 1.4 mg/m2 (max 2mg) IV on days 15, 22, 29, and 36
    • Prednisone 60mg/m2 (or equivalent corticosteroid) oral daily for 28 days on days 15 - 42
    • Erwinia asparaginase 25,000 IU/m2 IV three times a week on a MWF schedule for 2 weeks on days 29 - 42 (after a two week interval without Erwinia asparaginase administered on days 1 - 14) Upon cell count recovery, a
      Sponsor: Memorial Sloan Kettering Cancer Center

      Current Primary Outcome: proportion of patients who have a dose limiting toxicity (DLT) [ Time Frame: with in 6 weeks of starting the study drug ]

      DLTs are defined as any of the following: grade 4 pancreatitis, grade 4 hemorrhage, grade 4 thromboembolism, grade 4 hyperbilirubinemia and any grade 5 toxicity attributable (definitely, probably or possible) to Erwinia asparaginase.


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Memorial Sloan Kettering Cancer Center

      Dates:
      Date Received: January 5, 2016
      Date Started: January 2016
      Date Completion:
      Last Updated: January 5, 2017
      Last Verified: January 2017