A Phase III Study of Elacytarabine versus Investigator's Choice in Patients with Late-Stage Acute Myeloid Leukemia

Protocol
10-113
Full Title
A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients with Late Stage Acute Myeloid Leukaemia
Purpose

The purpose of this study is to evaluate the effectiveness of elacytarabine, an investigational drug, for the treatment of acute myeloid leukemia (AML) that has stopped responding to or has progressed despite two or three prior regimens of chemotherapy. Patients will be randomly assigned to receive elacytarabine or a standard therapy (investigator’s choice), but not both. <//p>

Elacytarabine is a new medicine that has put some patients with late-stage AML into remission. It induces cancer cell death by interfering with the cell’s DNA.

Eligibility

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

  • Patients must have AML that persists despite two or three prior regimens of therapy.
  • Patients under age 65 must have had cytarabine as one of their previous therapies.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Dan Douer at 212-639-2471.

Disease(s)
Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations