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Anti-metabolite

Vosaroxin + Cytarabine for Acute Myeloid Leukemia (VITAL Trial)

Phase 2

Waitlist Available

Led By Sanjay Mohan, 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

Must not have

Any previous treatment with vosaroxin

Active, uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of therapy up to 1 year

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with vosaroxin.

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I do not have an ongoing, untreated infection.

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I am currently receiving chemotherapy or radiation therapy.

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I have another serious illness besides cancer.

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My acute myeloid leukemia (AML) may have spread to my brain or spinal cord.

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I haven't had a heart attack, unstable angina, stroke, or mini-stroke in the last 3 months.

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I require dialysis for my kidney condition.

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I am HIV positive.

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I am 18-54 with AML and have certain genetic markers that are considered 'good risk'.

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I have been diagnosed with acute promyelocytic leukemia.

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I can't have anthracycline treatment due to my genetic condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Remission Rate (CR)

Secondary study objectives

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

Side effects data

From 2021 Phase 1 & 2 trial • 66 Patients • NCT01893320

31%

Febrile Neutropenia

22%

Lung Infection

19%

Sepsis

14%

Infection

Mucositis Oral

Hypokalemia

Fall

Catheter Related Infection

Respiratory Failure

Gait disturbance

Dehydration

Pharyngitis

Blood Bilirubin Increase

Blood Bilirubin Increased

Rectal Hemorrhage

Urinary Tract Infection

Dysartharia

Bone Pain

Erythema multiforme

Ileus

Conjunctivitis

Hallucinations

Multi-Organ Failure

Burn

Edema Face

Fatigue

Non-Cardiac Chest Pain

Acute Kidney Injury

Hypophosphatemia

Abdominal Pain

Back Pain

Gastrointestinal Disorders - Other

Generalized Weakness

Intracranial Hemorrhage

Nausea

Neoplasms benign, malignant and unspecified

Renal Calculi

Respiratory, thoracic and mediastinal disorders

Stroke

Syncope

Alanine Aminotransferase Increased

Arthritis

Aspartate Aminotransferase Increase

Hearing Impaired

Postnasal drip

Seizure

Soft Tissue Infection

Toothache

Urine discoloration

Wound Complication

Proctitis

Bone Infection

Delirium

Enterocolitis Infection

Skin Infection

Heart Failure

Hoarsness

Hyperglycemia

Hyperkalemia

Hypernatremia

Hypocalcemia

Hyponatremia

100%

80%

60%

40%

20%

Study treatment Arm

Vasoroxin + Decitabine

Phase I MTD Vosaroxin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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 / 16Eligibility criteria met