A Phase I Study of Erwinia Chrysanthemi Asparaginase in Older Patients Newly Diagnosed with Acute Lymphoblastic Leukemia

Full Title

A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Erwinia Chrysanthemi Asparaginase in Patients with Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older

Purpose

Patients age 60 and older diagnosed with acute lymphoblastic leukemia (ALL) cannot usually tolerate the intense therapies used to treat children with ALL. In this study, researchers are evaluating the safety of a drug called Erwinia Chrysanthemi asparaginase when used alone and in combination with chemotherapy in adults age 60 and older newly diagnosed with ALL.

Erwinia Chrysanthemi asparaginase is already approved to treat patients with ALL who cannot tolerate another form of asparaginase. It is routinely given to children with ALL in combination with chemotherapy and has been shown to improve treatment when compared with chemotherapy alone. Erwinia Chrysanthemi asparaginase may be safe to use in older adults because it remains in the body a relatively short time, enabling doctors to reverse any side effects that may occur. Erwinia Chrysanthemi asparaginase and the other chemotherapy drugs used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in this study must be newly diagnosed with Philadelphia chromosome-negative ALL.
  • Patients may not have received prior anticancer treatment.
  • This study is for patients age 60 and older.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.

Protocol

15-107

Phase

I

Investigator

Co-Investigators

Douer, Dan, MD

Locations