Trial · NCT01721876
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
NCT01721876, Phase 3, Completed, Boehringer Ingelheim; results first posted 2021-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2). Trials, record NCT01721876. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01721876
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
- NCT number
- NCT01721876
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 666 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Placebo, Volasertib, Cytarabine
- First posted
- 2012-11-06
- Last updated
- 2023-02-08
- Other registries' IDs
- eudract:2012-002487-27
- Results first posted
- 2021-11-19
- Limitations and caveats
- The final analysis presented in this report was conducted after 574 Overall Survival events had occurred. The final analysis was exploratory and descriptive.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (OR) | Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months. | OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period. |
| Secondary | Overall Survival (OS) | From randomization until death due to any cause, up to 1557 days. | OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive. |
| Secondary | Event-free Survival (EFS) | From randomization until disease progression or relapse or death from any cause, up to 1557 days. | EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first. |
| Secondary | Relapse-free Survival (RFS) | From randomization until disease progression or relapse or death from any cause, up to 1557 days. | RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (OR) | Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months. | The randomised set (RS) included all patients who had been randomised at the database snapshot. | Participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization until death due to any cause, up to 1557 days. | RS | Months | MEDIAN |
| SECONDARY | Event-free Survival (EFS) | From randomization until disease progression or relapse or death from any cause, up to 1557 days. | RS | Months | MEDIAN |
| SECONDARY | Relapse-free Survival (RFS) | From randomization until disease progression or relapse or death from any cause, up to 1557 days. | All patients in the RS who achieved best overall response of CR or CRi. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (OR) | Placebo + Low-dose Cytarabine | 38 | Participants | ||
| Objective Response (OR) | Volasertib + Low-dose Cytarabine | 123 | Participants | ||
| Overall Survival (OS) | Placebo + Low-dose Cytarabine | 6.5 | 95% Confidence Interval 4.9 to 8.0 | Months | |
| Overall Survival (OS) | Volasertib + Low-dose Cytarabine | 5.6 | 95% Confidence Interval 4.5 to 6.8 | Months | |
| Event-free Survival (EFS) | Placebo + Low-dose Cytarabine | 2.8 | 95% Confidence Interval 2.1 to 4.9 | Months | |
| Event-free Survival (EFS) | Volasertib + Low-dose Cytarabine | 3.3 | 95% Confidence Interval 2.6 to 4.2 | Months | |
| Relapse-free Survival (RFS) | Placebo + Low-dose Cytarabine | 18.7 | 95% Confidence Interval 11.3 to NA | Months | |
| Relapse-free Survival (RFS) | Volasertib + Low-dose Cytarabine | 13.1 | 95% Confidence Interval 6.2 to NA | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Low-dose Cytarabine | 222 | |
| Overall Study | STARTED | Volasertib + Low-dose Cytarabine | 444 | |
| Overall Study | Treated | Placebo + Low-dose Cytarabine | 221 | |
| Overall Study | Treated | Volasertib + Low-dose Cytarabine | 440 | |
| Overall Study | COMPLETED | Placebo + Low-dose Cytarabine | 0 | |
| Overall Study | COMPLETED | Volasertib + Low-dose Cytarabine | 0 | |
| Overall Study | NOT COMPLETED | Placebo + Low-dose Cytarabine | 222 | |
| Overall Study | NOT COMPLETED | Volasertib + Low-dose Cytarabine | 444 |
Source ClinicalTrials.gov
Adverse events844
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 | Subjects Assigned to Placebo + Low-dose Cytarabine | 53 | 222 | |
| other | Anaemia | Blood and lymphatic system disorders | Subjects Assigned to Volasertib + Low-dose Cytarabine | 137 | 439 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Subjects Assigned to Placebo + Low-dose Cytarabine | 28 | 222 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Subjects Assigned to Volasertib + Low-dose Cytarabine | 101 | 439 | |
| other | Leukopenia | Blood and lymphatic system disorders | Subjects Assigned to Placebo + Low-dose Cytarabine | 23 | 222 | |
| other | Leukopenia | Blood and lymphatic system disorders | Subjects Assigned to Volasertib + Low-dose Cytarabine | 45 | 439 | |
| other | Neutropenia | Blood and lymphatic system disorders | Subjects Assigned to Placebo + Low-dose Cytarabine | 34 | 222 | |
| other | Neutropenia | Blood and lymphatic system disorders | Subjects Assigned to Volasertib + Low-dose Cytarabine | 124 | 439 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Subjects Assigned to Placebo + Low-dose Cytarabine | 59 | 222 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Subjects Assigned to Volasertib + Low-dose Cytarabine | 163 | 439 |
1 to 10 of 844Source ClinicalTrials.gov
See all 844 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Subjects Assigned to Placebo + Low-dose Cytarabine | 40 | 222 |
| Total, all-cause mortality | Subjects Assigned to Volasertib + Low-dose Cytarabine | 138 | 439 |
| Total, other adverse events | Subjects Assigned to Placebo + Low-dose Cytarabine | 203 | 222 |
| Total, other adverse events | Subjects Assigned to Volasertib + Low-dose Cytarabine | 404 | 439 |
| Total, serious adverse events | Subjects Assigned to Placebo + Low-dose Cytarabine | 163 | 222 |
| Total, serious adverse events | Subjects Assigned to Volasertib + Low-dose Cytarabine | 380 | 439 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34646387 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Low-dose Cytarabine vs Volasertib + Low-dose Cytarabine: Objective Response (OR) | Trial comparisons |
| Subjects Assigned to Placebo + Low-dose Cytarabine vs Subjects Assigned to Volasertib + Low-dose Cytarabine: deaths from any cause | Trial comparisons |
| Subjects Assigned to Placebo + Low-dose Cytarabine vs Subjects Assigned to Volasertib + Low-dose 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/NCT01721876
GET https://conductscience.org/api/trials/v1/NCT01721876/events?page=2