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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
666
Objective Response (OR)
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.
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.
Overall Survival (OS)
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.
Time frame: From randomization until death due to any cause, up to 1557 days.
Event-free Survival (EFS)
EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.
Time frame: From randomization until disease progression or relapse or death from any cause, up to 1557 days.
Relapse-free Survival (RFS)
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.
Time frame: From randomization until disease progression or relapse or death from any cause, up to 1557 days.
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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
Vienna, Austria
AZ Sint-Jan Brugge
Bruges, Belgium
...and 112 more locations