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Anti-metabolite

Vosaroxin + Cytarabine for Acute Myeloid Leukemia (VITAL Trial)

Phase 2
Waitlist Available
Led By Stephen Strickland, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 at time of study entry
Morphologically confirmed new diagnosis of AML in accordance with World Health Organization (WHO) diagnostic criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of therapy up to 1 year
Awards & highlights

VITAL Trial Summary

This trial tests vosaroxin + cytarabine to see how well it works in treating patients with untreated AML.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, mouth sores, diarrhea and potential damage to organs such as the heart or liver.

VITAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have been newly diagnosed with AML according to WHO standards.
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I am 55 or older with AML, or 18-54 with high-risk AML.
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I am 55 or older with AML, or 18-54 with intermediate/high risk AML.
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I can handle strong chemotherapy with vosaroxin and cytarabine.

VITAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of therapy up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of therapy up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Remission Rate (CR)
Secondary outcome measures
Event-free Survival
Frequency of Grade 3-5 Adverse Event Related to Cytarabine and Vosaroxin (7+V)
Leukemia-free Survival (LFS or DFS)
+3 more
Other outcome measures
Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With DFS
Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With Disease Response
Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With OS

Side effects data

From 2021 Phase 1 & 2 trial • 66 Patients • NCT01893320
43%
Febrile Neutropenia
29%
Lung Infection
29%
Mucositis Oral
14%
Myocardial Infarction
14%
Sepsis
14%
Bone Pain
14%
Dehydration
14%
Hypomagnesemia
14%
Urinary Tract Infection
14%
Acute Kidney Injury
14%
Blood Bilirubin Increase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I MTD Vosaroxin
Vasoroxin + Decitabine

VITAL Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Vosaroxin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
214 Previous Clinical Trials
60,951 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,272 Total Patients Enrolled
Stephen Strickland, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
1 Previous Clinical Trials
~5 spots leftby Jun 2025
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