A Phase III Study of Sapacitabine in Elderly Patients Newly Diagnosed with Acute Myeloid Leukemia

Protocol
12-034
Full Title
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia
Phase
III
Disease Status
Newly Diagnosed
Purpose

Intensive chemotherapy is one way of treating acute myeloid leukemia (AML), but many older adults cannot tolerate the side effects of this approach. The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called sapacitabine in patients age 70 and older who are newly diagnosed with AML.

Sapacitabine kills cancer cells by causing breaks in their DNA (genetic material). It is a capsule that is taken orally (by mouth). It will be compared in this study to decitabine, which has been used for many years to treat older people with acute leukemia. Decitabine is given intravenously (by vein).

Patients in this study will be randomly assigned to receive either sapacitabine or decitabine.

Eligibility

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

  • Patients must be age 70 or older.
  • Patients must have AML that has not yet been treated.
  • Patients may not be candidates for intensive induction chemotherapy.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Ellin Berman at 212-639-7762.

Disease(s)
Geriatrics
Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations