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

• Sponsor: Vanderbilt-Ingram Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02658487
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 42
• Locations: 3
• Arm: 1
• Duration (Months): 76
• Patients Per Site: 14
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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 stopping them from spreading.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Cytarabine; Drug: Vosaroxin	Phase 2

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".

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

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

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

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

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

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

TERTIARY OBJECTIVES:

• 1. To describe the mutational burden of this cohort of AML patients.
• 1. To correlate genomic aberration with response rate, DFS, and OS.
• 1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Vosaroxin in Combination With Infusional Cytarabine in Patients With Untreated AML
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (vosaroxin, cytarabine) 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.

Drug: Cytarabine; Given IV; Other Names: .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 1-Beta-D-arabinofuranosylcytosine 1.beta.-D-Arabinofuranosylcytosine 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl- 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl- Alexan Ara-C ARA-cell Arabine Arabinofuranosylcytosine Arabinosylcytosine Aracytidine Aracytin Aracytine Beta-Cytosine Arabinoside CHX-3311 Cytarabinum Cytarbel Cytosar Cytosar-U Cytosine Arabinoside Cytosine-.beta.-arabinoside Cytosine-beta-arabinoside Erpalfa Starasid Tarabine PFS U 19920 U-19920 Udicil WR-28453 ; Drug: Vosaroxin; Given IV; Other Names: AG-7352 SNS-595 SPC 595 Voreloxin

Outcome Measures

Primary Outcome Measures

1. Complete Remission Rate (CR) [Up to 3 months]

   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

Secondary Outcome Measures

1. Event-free Survival [From start of therapy up to 1 year]

   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.

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

   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.

3. Leukemia-free Survival (LFS or DFS) [The time from complete remission to disease progression or death for any reason, assessed up to 1 year]

   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.

4. Overall Survival [The time from start of therapy to death, assessed up to 1 year]

   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.

5. Minimal Residual Disease [Up to 3 months]

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

6. Rate of CR/CRi [Up to 3 months]

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

Other Outcome Measures

1. Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With Disease Response [Up to 3 months]

2. Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With DFS [The time from complete remission to disease progression or death for any reason, assessed up to 1 year]

3. Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With OS [The time from start of therapy to death for any reason, assessed up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• 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 FLT3-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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06520
2	Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina	United States	29425
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt-Ingram Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Stephen Strickland, MD, Vanderbilt-Ingram Cancer Center
• Principal Investigator: Michael Savona, MD, Vanderbilt-Ingram Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 18, 2016

More Information

Additional Information:

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Publications

None provided.

• Responsible Party: Stephen Strickland, Assistant Professor of Medicine, Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT02658487
• Other Study ID Numbers: VICC HEM 1553; NCI-2015-01735; P30CA068485
• First Posted: Jan 18, 2016
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Sarcoma, Myeloid; Myelodysplastic Syndromes; Syndrome; Cytarabine

Study Results

Participant Flow

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 Detail	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
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
Period Title: Overall Study
STARTED	42
COMPLETED	26
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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 Participants	42
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 59.5%
>=65 years	17 40.5%
Age (Years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Years]	64.4
Sex: Female, Male (Count of Participants)
Female	13 31%
Male	29 69%
Race/Ethnicity, Customized (Count of Participants)
White	35 83.3%
Black or African American	5 11.9%
Unknown/unreported	2 4.8%
Region of Enrollment (participants) [Number]
United States	42 100%

Outcome Measures

1. Primary Outcome

Title	Complete Remission Rate (CR)
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

Outcome Measure Data

Analysis Population Description

Evaluable patients

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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
Measure Participants	42
Count of Participants [Participants]	20 47.6%

2. Secondary Outcome

Title	Event-free Survival
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

Outcome Measure Data

Analysis Population Description

All patients participated

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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
Measure Participants	42
Median (95% Confidence Interval) [months]	7.6

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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
Measure Participants	42
Number [adverse events]	133

4. Secondary Outcome

Title	Leukemia-free Survival (LFS or DFS)
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

Outcome Measure Data

Analysis Population Description

Patients who had complete remission after the therapy

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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
Measure Participants	20
Median (95% Confidence Interval) [months]	NA

5. Secondary Outcome

Title	Overall Survival
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

Outcome Measure Data

Analysis Population Description

All participated patients

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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
Measure Participants	42
Median (95% Confidence Interval) [months]	10.7

6. Secondary Outcome

Title	Minimal Residual Disease
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Rate of CR/CRi
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

Outcome Measure Data

Analysis Population Description

Evaluable patients

Arm/Group Title	Treatment (Vosaroxin, Cytarabine)
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
Measure Participants	42
Number (95% Confidence Interval) [Proportion of participants]	0.55 1.3%

8. Other Pre-specified Outcome

Title	Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With Disease Response
Time Frame	Up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With DFS
Time Frame	The time from complete remission to disease progression or death for any reason, assessed up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Correlate HSCT Comorbidity Index, Wheatley Index, and AML-Score Values With OS
Time Frame	The time from start of therapy to death for any reason, assessed up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
Arm/Group Title	Treatment (Vosaroxin, Cytarabine) Induction 1		Induction 2
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	18/33 (54.5%)		4/9 (44.4%)
Serious Adverse Events
	Treatment (Vosaroxin, Cytarabine) Induction 1		Induction 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/33 (30.3%)		5/9 (55.6%)
Blood and lymphatic system disorders
Febrile Neutropenia	1/33 (3%)	1	1/9 (11.1%)	1
Cardiac disorders
Chronic heart failure	0/33 (0%)	0	1/9 (11.1%)	1
Ventricular fibrillation	1/33 (3%)	1	0/9 (0%)	0
Gastrointestinal disorders
Acute sigmoid diverticulitis	1/33 (3%)	1	0/9 (0%)	0
Colitis	6/33 (18.2%)	8	1/9 (11.1%)	1
Typhlitis	1/33 (3%)	1	1/9 (11.1%)	1
Hepatobiliary disorders
Cholecystitis	1/33 (3%)	1	1/9 (11.1%)	1
Infections and infestations
Sepsis	2/33 (6.1%)	2	0/9 (0%)	0
Fungemia	1/33 (3%)	1	0/9 (0%)	0
Investigations
Electrocardiogram QT corrected interval prolonged	3/33 (9.1%)	4	0/9 (0%)	0
Psychiatric disorders
Altered mental state	0/33 (0%)	0	1/9 (11.1%)	1
Renal and urinary disorders
Hematuria	1/33 (3%)	1	0/9 (0%)	0
Acute kidney injury	1/33 (3%)	1	0/9 (0%)	0
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome	1/33 (3%)	1	0/9 (0%)	0
Respiratory failure	2/33 (6.1%)	2	0/9 (0%)	0
Dyspnea	0/33 (0%)	0	1/9 (11.1%)	1
Pleural effusion	0/33 (0%)	0	1/9 (11.1%)	1
Vascular disorders
Thromboembolic event - Related to Hickman line placement	0/33 (0%)	0	1/9 (11.1%)	1
Other (Not Including Serious) Adverse Events
	Treatment (Vosaroxin, Cytarabine) Induction 1		Induction 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/33 (100%)		9/9 (100%)
Blood and lymphatic system disorders
Anemia	10/33 (30.3%)	10	2/9 (22.2%)	2
Febrile Neutropenia	27/33 (81.8%)	33	5/9 (55.6%)	10
Thrombocytopenia	0/33 (0%)		1/9 (11.1%)	4
Transaminitis	0/33 (0%)	0	1/9 (11.1%)	1
Gastrointestinal disorders
Colitis	5/33 (15.2%)	5	0/9 (0%)	0
Diarrhea	26/33 (78.8%)	37	5/9 (55.6%)	19
Mucositis oral	11/33 (33.3%)	20	5/9 (55.6%)	9
Infections and infestations
Bacteremia/multiorgan failure	0/33 (0%)	0	1/9 (11.1%)	1
Concern for fungal infection	0/33 (0%)	0	1/9 (11.1%)	1
Staph bacteremia	0/33 (0%)	0	1/9 (11.1%)	1
Soft Tissue Infection	0/33 (0%)	0	1/9 (11.1%)	2
Investigations
Creatinine increased	2/33 (6.1%)	6	0/9 (0%)	0
Neutrophil count decreased	17/33 (51.5%)	36	4/9 (44.4%)	8
Platelet count decreased	21/33 (63.6%)	55	5/9 (55.6%)	20
Urine output decreased	2/33 (6.1%)	2	0/9 (0%)	0
White blood cell decreased	16/33 (48.5%)	29	5/9 (55.6%)	16
Neutropenic colitis	0/33 (0%)	0	1/9 (11.1%)	1
Worsening Platelet Count Decrease	1/33 (3%)	1	1/9 (11.1%)	1
Metabolism and nutrition disorders
Hyperkalemia	0/33 (0%)	0	1/9 (11.1%)	1
Anorexia	2/33 (6.1%)	2	0/9 (0%)	0
Hyperglycemia	5/33 (15.2%)	6	0/9 (0%)	0
Hypokalemia	4/33 (12.1%)	5	2/9 (22.2%)	4
Hypoalbuminemia	2/33 (6.1%)	2	0/9 (0%)	0
Hypocalcemia	2/33 (6.1%)	2	0/9 (0%)	0
Hyponatremia	4/33 (12.1%)	5	0/9 (0%)	0
Hypophosphatemia	3/33 (9.1%)	3	1/9 (11.1%)	1
Musculoskeletal and connective tissue disorders
Generalized muscle weakness	2/33 (6.1%)	2	0/9 (0%)	0
Psychiatric disorders
Confusion	3/33 (9.1%)	3	0/9 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/33 (3%)	1	1/9 (11.1%)	1
Hypoxia	2/33 (6.1%)	3	0/9 (0%)	0
Vascular disorders
Catheter related thorombosis	0/33 (0%)	0	1/9 (11.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.