Trial · NCT01191801
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
NCT01191801, Phase 3, Completed, Sunesis Pharmaceuticals; results first posted 2017-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML. Trials, record NCT01191801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
- NCT number
- NCT01191801
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 711 participants, actual
- Lead sponsor
- Sunesis Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia
- Interventions
- vosaroxin + cytarabine, placebo + cytarabine
- First posted
- 2010-08-31
- Last updated
- 2018-08-22
- Other registries' IDs
- eudract:2010-021961-61
- Results first posted
- 2017-05-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 5 years or duration of study | Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival |
| Secondary | Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria. | Up to 5 years or duration of study | Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts. |
| Secondary | All Cause Mortality | 30 Days | Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality |
| Secondary | All Cause Mortality | 60 Days | Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality |
| Other | Overall Remission (OR) Rate Based on the IWG Response Criteria | Up to 5 years or the duration of the study | Group A patient OR compared to Group B patient OR Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent. |
| Other | Event Free Survival (EFS) | Up to 5 years or duration of study | |
| Other | Leukemia-Free Survival (LFS) | Up to 5 years or the duration of the study | Durability of remission (CR) assessed by LFS |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 5 years or duration of study | The intent-to-treat (ITT) population which consists of all patients enrolled (randomly assigned to treatment group). | Months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria. | Up to 5 years or duration of study | The percentage of patients who achieved CR was adjudicated by the CPARR (Central Pathology and Response Review) panel using modified IWG response criteria. The outcome measure reflects the Intent to Treat Population. | percentage of particpants | NUMBER |
| SECONDARY | All Cause Mortality | 30 Days | Safety Population (705) | percentage of Participants in the Group | NUMBER |
| SECONDARY | All Cause Mortality | 60 Days | Safety Population (705) | percentage of Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Remission (OR) Rate Based on the IWG Response Criteria | Up to 5 years or the duration of the study | Intent to Treat Population | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Event Free Survival (EFS) | Up to 5 years or duration of study | Intent to Treat Population | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Leukemia-Free Survival (LFS) | Up to 5 years or the duration of the study | Subset of Intent to Treat patients that have a Measured CR | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Group A (Vosaroxin/Cytarabine) | 7.5 | 95% Confidence Interval 6.4 to 8.5 | Months | |
| Overall Survival | Group B (Placebo/Cytarabine) | 6.1 | 95% Confidence Interval 5.2 to 7.1 | Months | |
| Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria. | Group A (Vosaroxin/Cytarabine) | 30.1 | 95% Confidence Interval 25.3 to 35.1 | percentage of particpants | |
| Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria. | Group B (Placebo/Cytarabine) | 16.3 | 95% Confidence Interval 12.6 to 20.6 | percentage of particpants | |
| All Cause Mortality | Group A (Vosaroxin/Cytarabine) | 7.9 | 95% Confidence Interval 5.3 to 11.2 | percentage of Participants in the Group | |
| All Cause Mortality | Group B (Placebo/Cytarabine) | 6.6 | 95% Confidence Interval 4.2 to 9.7 | percentage of Participants in the Group | |
| All Cause Mortality | Group A (Vosaroxin/Cytarabine) | 19.7 | 95% Confidence Interval 15.7 to 24.2 | percentage of Participants | |
| All Cause Mortality | Group B (Placebo/Cytarabine) | 19.4 | 95% Confidence Interval 15.4 to 24.0 | percentage of Participants | |
| Overall Remission (OR) Rate Based on the IWG Response Criteria | Group A (Vosaroxin/Cytarabine) | 37.9 | 95% Confidence Interval 32.9 to 43.2 | percentage of participants | |
| Overall Remission (OR) Rate Based on the IWG Response Criteria | Group B (Placebo/Cytarabine) | 18.9 | 95% Confidence Interval 14.9 to 23.3 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A (Vosaroxin/Cytarabine) | 356 | |
| Overall Study | STARTED | Group B (Placebo/Cytarabine) | 355 | |
| Overall Study | COMPLETED | Group A (Vosaroxin/Cytarabine) | 40 | |
| Overall Study | COMPLETED | Group B (Placebo/Cytarabine) | 18 | |
| Overall Study | NOT COMPLETED | Group A (Vosaroxin/Cytarabine) | 316 | |
| Overall Study | NOT COMPLETED | Group B (Placebo/Cytarabine) | 337 |
Source ClinicalTrials.gov
Adverse events484
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Group A (Vosaroxin/Cytarabine) | 95 | 355 | |
| other | Anaemia | Blood and lymphatic system disorders | Group B (Placebo/Cytarabine) | 104 | 350 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group A (Vosaroxin/Cytarabine) | 143 | 355 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group B (Placebo/Cytarabine) | 97 | 350 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group A (Vosaroxin/Cytarabine) | 70 | 355 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group B (Placebo/Cytarabine) | 50 | 350 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group A (Vosaroxin/Cytarabine) | 88 | 355 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group B (Placebo/Cytarabine) | 90 | 350 | |
| other | Atrial fibrillation | Cardiac disorders | Group A (Vosaroxin/Cytarabine) | 22 | 355 | |
| other | Atrial fibrillation | Cardiac disorders | Group B (Placebo/Cytarabine) | 16 | 350 |
1 to 10 of 484Source ClinicalTrials.gov
See all 484 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A (Vosaroxin/Cytarabine) | 273 | 355 |
| Total, all-cause mortality | Group B (Placebo/Cytarabine) | 288 | 350 |
| Total, other adverse events | Group A (Vosaroxin/Cytarabine) | 354 | 355 |
| Total, other adverse events | Group B (Placebo/Cytarabine) | 349 | 350 |
| Total, serious adverse events | Group A (Vosaroxin/Cytarabine) | 197 | 355 |
| Total, serious adverse events | Group B (Placebo/Cytarabine) | 125 | 350 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26234174 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A (Vosaroxin/Cytarabine) vs Group B (Placebo/Cytarabine): deaths from any cause | Trial comparisons |
| Group A (Vosaroxin/Cytarabine) vs Group B (Placebo/Cytarabine): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01191801
GET https://conductscience.org/api/trials/v1/NCT01191801/events?page=2