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

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ClinicalTrials.gov Identifier: NCT02658487
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Results First Posted : June 9, 2020
Last Update Posted : May 27, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephen Strickland, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Acute Myeloid Leukemia With Multilineage Dysplasia
Myeloid Sarcoma
Secondary Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia
Therapy-Related Myelodysplastic Syndrome
Interventions Drug: Cytarabine
Drug: Vosaroxin
Enrollment 42
Recruitment Details The recruitment period for this trial was March 2016 to April 2019. Participants were recruited at Vanderbilt University Medical Center, Yale University, and University Medical School, South Carolina.
Pre-assignment Details 42 participants met all eligibility criteria and were enrolled on this study. Nine of the participants received a second induction.
Arm/Group Title Treatment (Vosaroxin, Cytarabine) Induction
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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: Given IV

Vosaroxin: Given IV

Period Title: Overall Study
Started 42
Completed 26
Not Completed 16
Reason Not Completed
Death             2
Disease progression             10
Alternative therapy             1
Adverse Event             1
Treatment Failure, circulating blasts             1
Refractory AML             1
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
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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: Given IV

Vosaroxin: Given IV

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  59.5%
>=65 years
17
  40.5%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 42 participants
64.4
(33.4 to 74.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
13
  31.0%
Male
29
  69.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
White
35
  83.3%
Black or African American
5
  11.9%
Unknown/unreported
2
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title Complete Remission Rate (CR)
Hide Description 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
Time Frame Up to 3 months
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Evaluable patients
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
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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: Given IV

Vosaroxin: Given IV

Overall Number of Participants Analyzed 42
Measure Type: Count of Participants
Unit of Measure: Participants
20
  47.6%
2.Secondary Outcome
Title Event-free Survival
Hide Description 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.
Time Frame From start of therapy up to 1 year
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All patients participated
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
Hide Arm/Group Description:

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: Given IV

Vosaroxin: Given IV

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
7.6 [1] 
(2.9 to NA)
[1]
insufficient number of participants with events for estimating
3.Secondary Outcome
Title Frequency of Grade 3-5 Adverse Event Related to Cytarabine and Vosaroxin (7+V)
Hide Description 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.
Time Frame Up to 3 months
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All participants
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
Hide Arm/Group Description:

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: Given IV

Vosaroxin: Given IV

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: adverse events
133
4.Secondary Outcome
Title Leukemia-free Survival (LFS or DFS)
Hide Description 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.
Time Frame The time from complete remission to disease progression or death for any reason, assessed up to 1 year
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Hide Analysis Population Description
Patients who had complete remission after the therapy
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
Hide Arm/Group Description:

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: Given IV

Vosaroxin: Given IV

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(13.1 to NA)
[1]
the median and upper bound are not estimable due to not long enough follow up
5.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame The time from start of therapy to death, assessed up to 1 year
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Hide Analysis Population Description
All participated patients
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
Hide Arm/Group Description:

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: Given IV

Vosaroxin: Given IV

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
10.7 [1] 
(7.4 to NA)
[1]
insufficient number of participants with events for estimating the upper bound
6.Secondary Outcome
Title Minimal Residual Disease
Hide Description Frequency of minimal residual disease (MRD) remaining after "7+V" induction and/or re-induction
Time Frame Up to 3 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Rate of CR/CRi
Hide Description Frequency of Complete Remission / Complete Remission with Incomplete Count Recovery (CR/CRi) after "7+V" induction and/or re-induction
Time Frame Up to 3 months
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Hide Analysis Population Description
Evaluable patients
Arm/Group Title Treatment (Vosaroxin, Cytarabine)
Hide Arm/Group Description:

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: Given IV

Vosaroxin: Given IV

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.55
(0.40 to 0.69)
8.Other Pre-specified Outcome
Title Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With Disease Response
Hide Description [Not Specified]
Time Frame Up to 3 months
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With DFS
Hide Description [Not Specified]
Time Frame The time from complete remission to disease progression or death for any reason, assessed up to 1 year
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With OS
Hide Description [Not Specified]
Time Frame The time from start of therapy to death for any reason, assessed up to 1 year
Outcome Measure Data Not Reported
Time Frame Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Vosaroxin, Cytarabine) Induction 1 Induction 2
Hide Arm/Group Description

Patients receive vosaroxin IV on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction I).

Cytarabine: Given IV

Vosaroxin: Given IV

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.
All-Cause Mortality
Treatment (Vosaroxin, Cytarabine) Induction 1 Induction 2
Affected / at Risk (%) Affected / at Risk (%)
Total   18/33 (54.55%)      4/9 (44.44%)    
Hide Serious Adverse Events
Treatment (Vosaroxin, Cytarabine) Induction 1 Induction 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/33 (30.30%)      5/9 (55.56%)    
Blood and lymphatic system disorders     
Febrile Neutropenia  1  1/33 (3.03%)  1 1/9 (11.11%)  1
Cardiac disorders     
Chronic heart failure  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Ventricular fibrillation  1  1/33 (3.03%)  1 0/9 (0.00%)  0
Gastrointestinal disorders     
Acute sigmoid diverticulitis  1  1/33 (3.03%)  1 0/9 (0.00%)  0
Colitis  1  6/33 (18.18%)  8 1/9 (11.11%)  1
Typhlitis  1  1/33 (3.03%)  1 1/9 (11.11%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/33 (3.03%)  1 1/9 (11.11%)  1
Infections and infestations     
Sepsis  1  2/33 (6.06%)  2 0/9 (0.00%)  0
Fungemia  1  1/33 (3.03%)  1 0/9 (0.00%)  0
Investigations     
Electrocardiogram QT corrected interval prolonged  1  3/33 (9.09%)  4 0/9 (0.00%)  0
Psychiatric disorders     
Altered mental state  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Renal and urinary disorders     
Hematuria  1  1/33 (3.03%)  1 0/9 (0.00%)  0
Acute kidney injury  1  1/33 (3.03%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult Respiratory Distress Syndrome  1  1/33 (3.03%)  1 0/9 (0.00%)  0
Respiratory failure  1  2/33 (6.06%)  2 0/9 (0.00%)  0
Dyspnea  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Pleural effusion  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Vascular disorders     
Thromboembolic event - Related to Hickman line placement  1  0/33 (0.00%)  0 1/9 (11.11%)  1
1
Term from vocabulary, CTCAE V4.03
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Vosaroxin, Cytarabine) Induction 1 Induction 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/33 (100.00%)      9/9 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  10/33 (30.30%)  10 2/9 (22.22%)  2
Febrile Neutropenia  1  27/33 (81.82%)  33 5/9 (55.56%)  10
Thrombocytopenia  1  0/33 (0.00%)  1/9 (11.11%)  4
Transaminitis  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders     
Colitis  1  5/33 (15.15%)  5 0/9 (0.00%)  0
Diarrhea  1  26/33 (78.79%)  37 5/9 (55.56%)  19
Mucositis oral  1  11/33 (33.33%)  20 5/9 (55.56%)  9
Infections and infestations     
Bacteremia/multiorgan failure  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Concern for fungal infection  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Staph bacteremia  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Soft Tissue Infection  1  0/33 (0.00%)  0 1/9 (11.11%)  2
Investigations     
Creatinine increased  1  2/33 (6.06%)  6 0/9 (0.00%)  0
Neutrophil count decreased  1  17/33 (51.52%)  36 4/9 (44.44%)  8
Platelet count decreased  1  21/33 (63.64%)  55 5/9 (55.56%)  20
Urine output decreased  1  2/33 (6.06%)  2 0/9 (0.00%)  0
White blood cell decreased  1  16/33 (48.48%)  29 5/9 (55.56%)  16
Neutropenic colitis  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Worsening Platelet Count Decrease  1  1/33 (3.03%)  1 1/9 (11.11%)  1
Metabolism and nutrition disorders     
Hyperkalemia  1  0/33 (0.00%)  0 1/9 (11.11%)  1
Anorexia  1  2/33 (6.06%)  2 0/9 (0.00%)  0
Hyperglycemia  1  5/33 (15.15%)  6 0/9 (0.00%)  0
Hypokalemia  1  4/33 (12.12%)  5 2/9 (22.22%)  4
Hypoalbuminemia  1  2/33 (6.06%)  2 0/9 (0.00%)  0
Hypocalcemia  1  2/33 (6.06%)  2 0/9 (0.00%)  0
Hyponatremia  1  4/33 (12.12%)  5 0/9 (0.00%)  0
Hypophosphatemia  1  3/33 (9.09%)  3 1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  2/33 (6.06%)  2 0/9 (0.00%)  0
Psychiatric disorders     
Confusion  1  3/33 (9.09%)  3 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/33 (3.03%)  1 1/9 (11.11%)  1
Hypoxia  1  2/33 (6.06%)  3 0/9 (0.00%)  0
Vascular disorders     
Catheter related thorombosis  1  0/33 (0.00%)  0 1/9 (11.11%)  1
1
Term from vocabulary, CTCAE V4.03
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen Strickland, MD
Organization: Vanderbilt University Medical Center
Phone: (615) 936-8422
EMail: stephen.strickland@vumc.org
Layout table for additonal information
Responsible Party: Stephen Strickland, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02658487    
Other Study ID Numbers: VICC HEM 1553
NCI-2015-01735 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA068485 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2016
First Posted: January 18, 2016
Results First Submitted: April 30, 2020
Results First Posted: June 9, 2020
Last Update Posted: May 27, 2021