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)

A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 666 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching Volasertib
DRUG	Volasertib	Volasertib
DRUG	Cytarabine	Cytarabine

Timeline

• Start date: 2013-01-29
• Primary completion: 2014-08-12
• Completion: 2021-05-28
• First posted: 2012-11-06
• Last updated: 2023-02-08
• Results posted: 2021-11-19

Locations

122 sites across 25 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Africa, South Korea, Spain, Taiwan