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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of therapy up to 1 year

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%

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,891 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,600 Total Patients Enrolled

Stephen Strickland, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study actively enrolling participants?

"According to clinicaltrials.gov, the study is not currently accepting new participants; the trial was initially posted on March 1st 2016 and last updated on September 28th 2022. Nevertheless, there are 3036 other studies actively seeking patients right now."

Answered by AI

What is the primary purpose of Vosaroxin in medical treatments?

"Vosaroxin is not only useful in treating leptomeningeal metastases, but also acute promyelocytic leukemia, meningeal leukemia and blast phase chronic myelocytic leukemia."

Answered by AI

How many applicants are being considered for participation in this clinical experiment?

"This study is not taking on any new participants currently. Initially posted on March 1st, 2016 and most recently updated September 28th 2022, individuals who are interested in participating in a related trial can explore the 2,801 studies recruiting for syndromes or 235 trials with Vosaroxin as an active component."

Answered by AI

Can you elaborate on the other research that has utilized Vosaroxin?

"Currently, there are 235 live trials focusing on Vosaroxin with 60 of them in their final stage. Out of the 9779 locations operating research for this drug, a handful can be found in New york City."

Answered by AI

Has the government sanctioned Vosaroxin for medical use?

"Although there is evidence to suggest that Vosaroxin is safe, its efficacy has yet to be established. We thus rate it a 2 on the safety scale of 1-3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia

Sanjay Mohan 2016. "Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02658487.

All > Acute Myeloid Leukemia > Aml