Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
Primary Purpose
Leukemia, Myeloid, Acute
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vosaroxin and Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Vosaroxin, Cytarabine, Remission Induction, Safety, Progression-Free Survival, Mortality Rate, Length of Stay
Eligibility Criteria
Inclusion Criteria:
- Age > 60 years
- A diagnosis of AML based on WHO classification (>20% myeloblasts in peripheral blood or bone marrow)
- No previous treatment with chemotherapy for AML, other than hydroxyurea. Previous treatment with hypomethylating agents is acceptable
- Patients must have an ECOG (Zubrod) performance status of 0-2 (see Appendix I).
- Patients must have adequate hepatic function with a total bilirubin < 1.5 times upper limit normal (ULN) other than cases of Gilbert disease, and ALT and AST < 2.5 times ULN; and adequate renal function as defined by a serum creatinine < 2 times ULN.
- Clinically significant nonhematologic toxicity after prior therapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
- Patients must have the ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to initiation of treatment
- Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
Exclusion Criteria:
- Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Patients with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
- A diagnosis of acute promyelocytic leukemia (APL). The study does not require to rule APL out for every subject. However, if there is clinical suspicion for APL, such diagnosis has to be ruled out before initiation of treatment.
- Active malignancy currently undergoing chemo or radiation therapy. Hormone therapy is acceptable.
- Active serious infection that at the discretion of treating physician makes patient ineligible for chemotherapy.
Sites / Locations
- Indiana University Health Hospital
- Indiana University Health Melvin and Bren Simon Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vosaroxin and Cytarabine
Arm Description
Outcomes
Primary Outcome Measures
Rate of Complete Remission
Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)
Secondary Outcome Measures
Procedure or Procedure Related Adverse Events
Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02485353
Brief Title
Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
Official Title
Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Safety concerns
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
May 2, 2016 (Actual)
Study Completion Date
February 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hamid Sayar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.
Detailed Description
Primary objective: rate of complete remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction; (4) 30- and 60-day mortality rate.
The treatment period will include up to 4 cycles of treatment (induction 1, induction 2, consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will be considered day 1.
Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L.
Up to 2 cycles of consolidation treatment may be completed by eligible patients in remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) if safety parameters are met.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
Vosaroxin, Cytarabine, Remission Induction, Safety, Progression-Free Survival, Mortality Rate, Length of Stay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vosaroxin and Cytarabine
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Vosaroxin and Cytarabine
Primary Outcome Measure Information:
Title
Rate of Complete Remission
Description
Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Procedure or Procedure Related Adverse Events
Description
Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 60 years
A diagnosis of AML based on WHO classification (>20% myeloblasts in peripheral blood or bone marrow)
No previous treatment with chemotherapy for AML, other than hydroxyurea. Previous treatment with hypomethylating agents is acceptable
Patients must have an ECOG (Zubrod) performance status of 0-2 (see Appendix I).
Patients must have adequate hepatic function with a total bilirubin < 1.5 times upper limit normal (ULN) other than cases of Gilbert disease, and ALT and AST < 2.5 times ULN; and adequate renal function as defined by a serum creatinine < 2 times ULN.
Clinically significant nonhematologic toxicity after prior therapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
Patients must have the ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to initiation of treatment
Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
Exclusion Criteria:
Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Patients with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
A diagnosis of acute promyelocytic leukemia (APL). The study does not require to rule APL out for every subject. However, if there is clinical suspicion for APL, such diagnosis has to be ruled out before initiation of treatment.
Active malignancy currently undergoing chemo or radiation therapy. Hormone therapy is acceptable.
Active serious infection that at the discretion of treating physician makes patient ineligible for chemotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Sayar, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
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