Leukemia, Myeloid, AcuteNCT02485353
Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
A study testing Vosaroxin and Cytarabine in people with Leukemia, Myeloid, Acute, run by Hamid Sayar at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Vosaroxin and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2015to 16 Feb 2017
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
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.
Read the 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.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- Vosaroxin and Cytarabine
- Keywords
- Vosaroxin, Cytarabine, Remission Induction, Safety, Progression-Free Survival, Mortality Rate, Length of Stay
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vosaroxin and CytarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Vosaroxin and Cytarabine | Other | Not described Receives: Drug: Vosaroxin and Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months
Secondary outcomes (1)
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)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start20 Oct 2015
- Primary completion2 May 2016
- Study completion16 Feb 2017
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamid Sayar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamid Sayar, Indiana University
- Investigators
- Hamid Sayar, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485353
- Sponsor's protocol ID
- IUSCC-0525
- Status last verified
- Aug 2017
- First submitted
- 26 Jun 2015
- Last updated
- 20 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML
- ClinicalTrials.gov ID
- NCT02485353
- Acronym / sponsor ID
- IUSCC-0525
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Vosaroxin, Cytarabine, Remission Induction, Safety, Progression-Free Survival, Mortality Rate, Length of Stay
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hamid SayarUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 2 May 2016 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 20 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vosaroxin and Cytarabine | Other | Drug: Vosaroxin and Cytarabine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vosaroxin and Cytarabine | Drug | Vosaroxin and Cytarabine |
Primary outcome
Rate of Complete Remission
Time frame: 2 months
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)
1 secondary outcome
Procedure or Procedure Related Adverse Events
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Sayar, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vosaroxin and Cytarabine in people with Leukemia, Myeloid, Acute, run by Hamid Sayar at 2 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2017). 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?
Rate of Complete Remission (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2017.