Trial · NCT02658487
Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia
NCT02658487, Phase 2, Completed, Vanderbilt-Ingram Cancer Center; results first posted 2020-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia. Trials, record NCT02658487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02658487
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia
- NCT number
- NCT02658487
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
Acute Myeloid Leukemia (AML), 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
- Cytarabine, Vosaroxin
- First posted
- 2016-01-18
- Last updated
- 2025-04-15
- Results first posted
- 2020-06-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Minimal Residual Disease | Up to 3 months | Frequency of minimal residual disease (MRD) remaining after "7+V" induction and/or re-induction |
| Secondary | 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 | Correlation of Three Standard Prognostic Scores of AML Risk With Disease Response | Up to 3 months | Correlate hematopoietic stem cell transplant (HSCT) comorbidity index, Wheatley Index, and AML-Score values with disease response |
| Other | 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 | Correlation of three standard prognostic scores of AML risk with disease free survival |
| Other | Correlation of Standard Prognostic Scores of AML Risk With Survival | The time from start of therapy to death for any reason, assessed up to 1 year | Correlate HSCT comorbidity index, Wheatley Index, and AML-Score values with overall survival |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission Rate (CR) | Up to 3 months | Evaluable patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-free Survival | From start of therapy up to 1 year | All patients participated | months | MEDIAN |
| SECONDARY | Frequency of Grade 3-5 Adverse Event Related to Cytarabine and Vosaroxin (7+V) | Up to 3 months | All participants | adverse events | NUMBER |
| SECONDARY | Leukemia-free Survival (LFS or DFS) | The time from complete remission to disease progression or death for any reason, assessed up to 1 year | Patients who had complete remission after the therapy | months | MEDIAN |
| SECONDARY | Overall Survival | The time from start of therapy to death, assessed up to 1 year | All participated patients | months | MEDIAN |
| SECONDARY | Minimal Residual Disease | Up to 3 months | When this study was designed, it was anticipated that the data needed to calculate MRD was going to be available from standard of care. However, this ended up not being the case. MRD requires NGS testing and the study did not have budget to cover this testing. Since the NGS was not part of the standard of care for these patients, these data were not available to collect as part of the study. There is no intention to go back and report data for this Outcome Measure if funding became available. | ||
| SECONDARY | Rate of CR/CRi | Up to 3 months | Evaluable patients | Proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Correlation of Three Standard Prognostic Scores of AML Risk With Disease Response | Up to 3 months | Data for this outcome measure were not collected. | ||
| OTHER_PRE_SPECIFIED | 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 | Data for this outcome measure were not collected. | ||
| OTHER_PRE_SPECIFIED | Correlation of Standard Prognostic Scores of AML Risk With Survival | The time from start of therapy to death for any reason, assessed up to 1 year | Data for this outcome measure were not collected. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission Rate (CR) | Treatment (Vosaroxin, Cytarabine) | 20 | Participants | ||
| Event-free Survival | Treatment (Vosaroxin, Cytarabine) | 7.6 | 95% Confidence Interval 2.9 to NA | months | |
| Frequency of Grade 3-5 Adverse Event Related to Cytarabine and Vosaroxin (7+V) | Treatment (Vosaroxin, Cytarabine) | 133 | adverse events | ||
| Leukemia-free Survival (LFS or DFS) | Treatment (Vosaroxin, Cytarabine) | NA | 95% Confidence Interval 13.1 to NA | months | |
| Overall Survival | Treatment (Vosaroxin, Cytarabine) | 10.7 | 95% Confidence Interval 7.4 to NA | months | |
| Rate of CR/CRi | Treatment (Vosaroxin, Cytarabine) | 0.55 | 95% Confidence Interval 0.40 to 0.69 | Proportion of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Vosaroxin, Cytarabine) Induction | 42 | |
| Overall Study | COMPLETED | Treatment (Vosaroxin, Cytarabine) Induction | 26 | |
| Overall Study | NOT COMPLETED | Treatment (Vosaroxin, Cytarabine) Induction | 16 |
Source ClinicalTrials.gov
Adverse events98
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 | Anemia | Blood and lymphatic system disorders | Treatment (Vosaroxin, Cytarabine) Induction 1 | 10 | 33 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Induction 2 | 2 | 9 | 2 |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Treatment (Vosaroxin, Cytarabine) Induction 1 | 27 | 33 | 33 |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Induction 2 | 5 | 9 | 10 |
| other | Creatinine increased | Investigations | Treatment (Vosaroxin, Cytarabine) Induction 1 | 2 | 33 | 6 |
| other | Creatinine increased | Investigations | Induction 2 | 0 | 9 | 0 |
| other | Neutrophil count decreased | Investigations | Treatment (Vosaroxin, Cytarabine) Induction 1 | 17 | 33 | 36 |
| other | Neutrophil count decreased | Investigations | Induction 2 | 4 | 9 | 8 |
| other | Platelet count decreased | Investigations | Treatment (Vosaroxin, Cytarabine) Induction 1 | 21 | 33 | 55 |
| other | Platelet count decreased | Investigations | Induction 2 | 5 | 9 | 20 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Vosaroxin, Cytarabine) Induction 1 | 18 | 33 |
| Total, all-cause mortality | Induction 2 | 4 | 9 |
| Total, other adverse events | Treatment (Vosaroxin, Cytarabine) Induction 1 | 33 | 33 |
| Total, other adverse events | Induction 2 | 9 | 9 |
| Total, serious adverse events | Treatment (Vosaroxin, Cytarabine) Induction 1 | 10 | 33 |
| Total, serious adverse events | Induction 2 | 5 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA068485 | Cancer Center Support Grant | PARK, BEN HO | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 1995 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Vosaroxin, Cytarabine) Induction 1 vs Induction 2: deaths from any cause | Trial comparisons |
| Treatment (Vosaroxin, Cytarabine) Induction 1 vs Induction 2: 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/NCT02658487
GET https://conductscience.org/api/trials/v1/NCT02658487/events?page=2