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)

Phase 3

Completed

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: Placebo; Drug: Volasertib; Drug: Cytarabine

• Registration Number: NCT01721876
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Study Start: 2013-01-29
• Primary Completion: 2014-08-12
• Disposition First Submitted: 2014-10-14
• Disposition First Submitted QC: 2014-11-19
• Disposition First Posted: 2014-12-04
• Study Completion: 2021-05-28
• Results First Submitted: 2021-09-09
• Results First Submitted QC: 2021-10-25
• Results First Posted: 2021-11-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 666

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Cytarabine	Placebo	-
Volasertib and Cytarabine	Volasertib	-
Volasertib and Cytarabine	Cytarabine	-
Placebo and Cytarabine	Cytarabine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (122)

University of California; 🇺🇸 Los Angeles, California, United States

St. Luke's Hospital Association of Duluth, Inc.; 🇺🇸 Duluth, Minnesota, United States

Henry-Joyce Cancer Clinic; 🇺🇸 Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Fundacion COIR; 🇦🇷 Mendoza, Argentina

Hospital Central de Salud Zenón Santillan; 🇦🇷 San Miguel de Tucumán, Argentina

LKH-Univ. Hospital Graz; 🇦🇹 Graz, Austria

LKH Leoben; 🇦🇹 Leoben, Austria

Hospital Hietzing; 🇦🇹 Wien, Austria

AZ Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

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