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NCT01721876 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 666
- Enrollment target
NCT01721876: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01721876 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 666 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721876, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 666 participants
- Enrollment target
Study Summary
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Cytarabine
- DRUG Volasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2013-01-29 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 3 |
What the finished NCT01721876 record still lists
NCT01721876 is an interventional study that assigns participants to a tested intervention. The registered 666 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01721876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721876 about?
NCT01721876 is a clinical study titled "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)". To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
What is the current status of trial NCT01721876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2013-01-29. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT01721876?
The interventions under investigation include: Placebo (DRUG), Cytarabine (DRUG), Volasertib (DRUG).
Who is sponsoring clinical trial NCT01721876?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01721876's enrollment target sits among peer trials
666 551st of 2000 higher than 1,449 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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