This pilot phase II trial studies how well vosaroxin and cytarabine work in treating adult patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Additional locations may be listed on ClinicalTrials.gov for NCT02485353.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Rate of complete remission, including complete remission with incomplete platelet recovery (CRp) and complete remission with incomplete blood count recovery (CRi).
SECONDARY OBJECTIVES:
I. Safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy.
II. Progression-free survival.
III. Length of stay in hospital for induction.
IV. 30- and 60-day mortality rate.
OUTLINE:
INDUCTION: Patients receive vosaroxin intravenously (IV) over 10 minutes on days 1 and 4 and cytarabine IV over 2 hours on days 1-5. Patients with residual disease may receive a second induction course at the discretion of the treating physician and/or principal investigator. Patients achieving remission after the induction course/courses proceed to consolidation therapy.
CONSOLIDATION: Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and cytarabine IV over 2 hours on days 1-5. Patients in remission (CR or CRp) may receive a second consolidation course at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorS. Hamid H. Sayar
