Vosaroxin + Cytarabine for Acute Myeloid Leukemia
(VITAL Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySanjay Mohan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Vanderbilt-Ingram Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well vosaroxin and cytarabine work in treating patients with 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.

Eligibility Criteria

This trial is for adults with untreated acute myeloid leukemia (AML). Participants must be able to tolerate intensive therapy, have an ECOG performance status of 0-2, and meet specific age and risk criteria. They should not have uncontrolled infections or diseases, certain heart conditions, CNS involvement of AML, or a history of other recent malignancies.

Inclusion Criteria

Total bilirubin =< 1.5 x upper limit of normal unless clearly related to Gilbert's disease, hemolysis or leukemic infiltrate

I can take care of myself and am up and about more than half of my waking hours.

I have been newly diagnosed with AML according to WHO standards.

+7 more

Exclusion Criteria

I have never been treated with vosaroxin.

I do not have an ongoing, untreated infection.

Pregnant or breastfeeding

+12 more

Participant Groups

The trial is testing the effectiveness of vosaroxin combined with cytarabine in treating patients with AML. Vosaroxin and cytarabine are chemotherapy drugs that work by stopping cancer cells from growing and spreading.

1Treatment groups

Experimental Treatment

Group I: Treatment (vosaroxin, cytarabine)Experimental Treatment2 Interventions

Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I). Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction II) 14-57 days after day 1 of Induction I.

Cytarabine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Cytosar-U for: