Clinical Trials

A Phase III Study of Cytarabine with or without Vosaroxin in Patients with First Relapsed or Refractory Acute Myeloid Leukemia

Protocol
11-094
Full Title
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
Purpose

In this study, researchers are looking at how safe and effective it is to use vosaroxin and cytarabine together for the treatment of acute myeloid leukemia (AML). They will compare this therapy with cytarabine given alone.

Vosaroxin is an investigational medication and has been given to more than 550 people with different kinds of cancer, including AML. Cytarabine is a marketed medication commonly used to treat AML. The study will determine if survival is different between the two treatment groups.

Investigator
Virginia M. Klimek, MD
Virginia M. Klimek - Physician Profile
Co-Investigators
Martin S. Tallman, MD -- Chief, Leukemia Service
Martin S. Tallman - Physician Profile
Eligibility

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

  • Patients must have AML that has returned or persisted despite standard therapy.
  • Patients may have had up to two regimens of induction chemotherapy.
  • Patients whose AML relapsed within 90 days of an intermediate or high-dose cytarabine-based therapy or who had a bone marrow or stem cell transplant within 90 days of entering the study may not participate.
  • 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. Virginia Klimek at 212-639-6519.

Disease(s)
Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations
Related Diseases