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Acute Myeloid Leukemia (AML)Phase 2VITALNCT02658487

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

A Phase 2 study testing Cytarabine and Vosaroxin in people with Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cytarabine and Vosaroxin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesUnited States
Study dates
Mar 2016to Sep 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide informed consent
  • Ability to tolerate intensive therapy with vosaroxin 90 mg/m^2 and cytarabine
  • 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
  • Patients who have received hydroxyurea alone or have previously received "non-cytotoxic" therapies for myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) (e.g., thalidomide or lenalidomide, 5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose Cytoxan, tyrosine kinase or dual tyrosine kinase [TK]/SRC proto-oncogene, non-receptor tyrosine kinase [src] inhibitors) will be allowed
  • Serum creatinine =< 2.0 mg/dL
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  • Hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) =< 2.5 x upper limit of normal
  • Total bilirubin =< 1.5 x upper limit of normal unless clearly related to Gilbert's disease, hemolysis or leukemic infiltrate
  • FOR PATIENTS IN STAGE 1 (PATIENTS #1-#17)
  • >= 55 years of age with AML of any risk classification, or 18-54 years of age with high-risk AML disease based on one of the following:
  • Antecedent hematologic disorder including myelodysplasia (MDS)-related AML (MDS/AML) and prior myeloproliferative disorder (MPD)
  • Treatment-related myeloid neoplasms (t-AML/t-MDS)
  • AML with FMS-like tyrosine kinase 3 (FLT3) - internal tandem duplication (ITD)
  • Myeloid sarcoma
  • AML with multilineage dysplasia (AML-MLD)
  • Adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q or 17p; t(6;9); t(9;22); trisomy 8; trisomy 13; trisomy 21; complex karyotypes (>= 3 clonal abnormalities); monosomal karyotypes
  • FOR PATIENTS IN STAGE 2 (ENROLLED PATIENT #18 AND BEYOND)
  • >= 55 years of age with AML of any risk classification, or 18-54 years of age with intermediate or high risk AML as defined by National Comprehensive Cancer Network (NCCN) risk assignment

Who cannot join

  • STAGES 1 AND 2
  • Patients with acute promyelocytic leukemia (APL) as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or fluorescence in situ hybridization (FISH) or molecular testing
  • Any previous treatment with vosaroxin
  • Concomitant chemotherapy, radiation therapy
  • For patients with hyperleukocytosis with > 50,000 blasts/μL; leukapheresis or hydroxyurea may be used prior to study drug administration for cytoreduction at the discretion of the treating physician
  • Active, uncontrolled infection
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  • Patients with infection under active treatment and controlled with antibiotics, antivirals, or antifungals are eligible
  • Chronic hepatitis is acceptable
  • Active, uncontrolled graft vs. host disease (GVHD) following allogeneic transplant for non-AML condition (e.g. MDS, lymphoid malignancy, aplastic anemia); patients with GVHD controlled on stable doses of immunosuppressants are eligible
  • Presence of other life-threatening illness
  • Left ventricular ejection fraction (LVEF) < 40% as measured by echocardiogram or multi gated acquisition scan (MUGA)
  • Known or suspected central nervous system (CNS) involvement of active AML
  • Other active malignancies including other hematologic malignancies or other malignancies within 12 months before randomization, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
  • History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before randomization
  • Prior or current therapy:
  • Hydroxyurea or medications to reduce blast count within 24 hours before randomization
  • Treatment with an investigational product within 14 days before randomization, or not recovered from all acute effects of previously administered investigational products
  • Renal insufficiency requiring hemodialysis or peritoneal dialysis
  • Pregnant or breastfeeding
  • Known human immunodeficiency virus (HIV) seropositivity
  • Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
  • ADDITIONAL EXCLUSION CRITERIA APPLIED TO STAGE 1
  • Patients 18-54 years of age with "good risk" AML defined as the presence of t(8;21), inv(16), or t(16;16) as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or FISH
  • Patients with t(8;21), inv(16), t(16;16) who are unable to receive anthracycline based induction will be allowed to enroll provided the medical reason they are unable to receive anthracyclines is clearly documented and provided they fulfill all other eligibility and criteria

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Phase II Trial of Vosaroxin in Combination With Infusional Cytarabine in Patients With Untreated AML

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the rate of complete remission (CR) after induction therapy with the combination of "7+V" (vosaroxin and standard dose infusional cytosine arabinoside [ara-C]) for patients with newly diagnosed, previously untreated acute myelogenous leukemia (AML).

SECONDARY OBJECTIVES:

  1. Frequency of grade 3-5 adverse events related to administration of "7+V".

II. To evaluate for the presence of minimal residual disease (MRD) remaining after "7+V" induction and/or re-induction.

III. To determine the CR/CR with incomplete blood count recovery (CRi) rate after one and/or 2 cycles of "7+V" induction.

IV. To determine the time to neutrophil and platelet recovery following "7+V" induction.

  1. To assess disease-free survival (DFS) at 1 year (yr) of patients achieving CR/CRi after "7+V" induction.

VI. To assess overall survival (OS) at 1 yr of all patients receiving protocol-defined therapy.

VII. To determine the correlation of hematopoietic stem cell transplant (HSCT) comorbidity index and Wheatley Index scores with disease response, DFS and OS.

TERTIARY OBJECTIVES:

  • I. To describe the mutational burden of this cohort of AML patients.
  • II. To correlate genomic aberration with response rate, DFS, and OS.
  • III. To determine the number of patients treated with vosaroxin who eventually go to allogeneic HSCT.

OUTLINE:

Patients receive vosaroxin intravenously (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-1

After completion of study treatment, patients are followed every 3 months for 1 year.

Being tested
Cytarabine, Vosaroxin
Medical subject headings
Leukemia, Myeloid, Acute, Sarcoma, Myeloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given IV

  • VosaroxinDrug

    Also called AG-7352, SNS-595, SPC 595, Voreloxin

    Given IV

Study groups in NCT02658487
Study groupRoleWhat they receive
Treatment (vosaroxin, cytarabine)ExperimentalPatients 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.
Receives: Drug: Cytarabine; Drug: Vosaroxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Remission Rate (CR)

    CR is calculated as the percentage of patients with complete remission after the therapy. The response criteria is based on International Working Group Criteria. Complete Remission: Neutrophils(cells/μl)>1000, Platelets (plt/μl)≥ 100,000,Bone marrow blasts (%) <5; CR with incomplete count recovery (CRi): meets criteria for CR except for neutrophils ≤1000 or Meets criteria for CR except for platelets< 100,000; Partial Remission: CR except for Bone marrow blasts (%) Decrease of ≥ 50% to value between 5% and 25%; Treatment Failure:Persistent acute myeloid leukemia in blood or bone marrow, or therapy fails to achieve a remission of any category, or death prior to response assessment

    Measured: Up to 3 months

Secondary outcomes (6)

  1. Event-free Survival

    Survival distribution will be estimated using the method of Kaplan and Meier. Event-free survival time is defined as the time from start of therapy to progression or death for any reason (which ever comes first), and those alive without progression are censored at the last day of follow up.

    Measured: From start of therapy up to 1 year

  2. Frequency of Grade 3-5 Adverse Event Related to Cytarabine and Vosaroxin (7+V)

    Events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Counts of all events are summed up.

    Measured: Up to 3 months

  3. Leukemia-free Survival (LFS or DFS)

    Survival distribution will be estimated using the method of Kaplan and Meier. LFS time is defined as the time from complete remission to disease progression or death for any reason and those disease free and alive are censored at the last day of follow up.

    Measured: The time from complete remission to disease progression or death for any reason, assessed up to 1 year

  4. Overall Survival

    Survival distribution will be estimated using the method of Kaplan and Meier. The overall survival time is defined as time from start of therapy to death of any reason. Those alive are censored at the last day of known alive.

    Measured: The time from start of therapy to death, assessed up to 1 year

  5. Minimal Residual Disease

    Frequency of minimal residual disease (MRD) remaining after "7+V" induction and/or re-induction

    Measured: Up to 3 months

  6. Rate of CR/CRi

    Frequency of Complete Remission / Complete Remission with Incomplete Count Recovery (CR/CRi) after "7+V" induction and/or re-induction

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionApr 2019
  4. Study completionSep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02658487
Sponsor's protocol ID
VICC HEM 1553
Other IDs
NCI-2015-01735, P30CA068485
Acronym
VITAL
Status last verified
Apr 2025
First submitted
14 Jan 2016
Last updated
15 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine and Vosaroxin in people with Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Remission Rate (CR) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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