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)
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|ClinicalTrials.gov Identifier: NCT01721876|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Last Update Posted : May 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Drug: Placebo Drug: Volasertib Drug: Cytarabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||666 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Actual Study Start Date :||January 29, 2013|
|Actual Primary Completion Date :||August 12, 2014|
|Estimated Study Completion Date :||June 1, 2021|
|Experimental: Volasertib and Cytarabine||
|Placebo Comparator: Placebo and Cytarabine||
Placebo matching Volasertib
- Objective Response (OR) [ Time Frame: 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. Objective response (CR + CRi) was also analysed by the stratification factors eastern cooperative oncology group (ECOG) performance score (PS) and type of acute myeloid leukaemia (AML).
- Overall survival (OS) [ Time Frame: 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.
- Event-free survival (EFS) [ Time Frame: 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.
- Relapse-free survival (RFS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721876
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|