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)
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 666
Not provided
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)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
HOP Côte de Nacre
🇫🇷Caen, France
HOP Haut-Lévêque
🇫🇷Pessac, France
Hospital Doutor Amaral Carvalho
🇧🇷Jau, Brazil
Fundacion COIR
🇦🇷Mendoza, Argentina
University of California
🇺🇸Los Angeles, California, United States
Yvoir - UNIV UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
HOP Amiens-Picardie Sud
🇫🇷Amiens, France
St. Luke's Hospital Association of Duluth, Inc.
🇺🇸Duluth, Minnesota, United States
HOP Dupuytren 1
🇫🇷Limoges Cedex 1, France
Univ. Gen. Hosp. of Ioannina
🇬🇷Ioannina, Greece
HOP Pontchaillou
🇫🇷Rennes Cedex 9, France
INS Universitaire du Cancer
🇫🇷Toulouse, France
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
🇭🇺Szeged, Hungary
University of Fukui Hospital
🇯🇵Fukui, Yoshida-gun, Japan
Amsterdam UMC Locatie VUMC
🇳🇱Amsterdam, Netherlands
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
City Hospital Torun, Department of Hematology
🇵🇱Torun, Poland
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Politècnic La Fe
🇪🇸Valencia, Spain
St. John Medical College and hospital
🇮🇳Bangalore, India
Tata Memorial Hospital
🇮🇳Mumbai, India
LKH-Univ. Hospital Graz
🇦🇹Graz, Austria
Hospital Hietzing
🇦🇹Wien, Austria
Sykehuset Østfold Kalnes
🇳🇴Grålum, Norway
LKH Leoben
🇦🇹Leoben, Austria
Hospital Universitario Dr Jose Eleuterio Gonzalez
🇲🇽Monterrey, Mexico
CHULN, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Meilahden sairaala
🇫🇮Helsinki, Finland
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
🇵🇹Porto, Portugal
IPO Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Haukeland Universitetssykehus
🇳🇴Bergen, Norway
Chang-Hua Christian Hospital
🇨🇳ChangHua, Taiwan
Montreal General Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Klinikum rechts der Isar der Technischen Universität München
🇩🇪München, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Henry-Joyce Cancer Clinic
🇺🇸Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hospital Central de Salud Zenón Santillan
🇦🇷San Miguel de Tucumán, Argentina
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Belgium
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
Roeselare - HOSP AZ Delta
🇧🇪Roeselare, Belgium
Hospital Mãe de Deus
🇧🇷Porto Alegre, Brazil
H.C.da Fac. de Medicina de Ribeirao Preto
🇧🇷Ribeirao Preto, Brazil
University of Alberta Hospital (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
TYKS, Sisätautien klinikka
🇫🇮Turku, Finland
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Migration Data, Canada
Univ. Hospital Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
University Hospital Plzen, Plzen-Lochotin
🇨🇿Plzen - Lochotin, Czechia
HOP Michallon
🇫🇷La Tronche, France
HOP André Mignot
🇫🇷Le Chesnay, France
INS Paoli-Calmettes
🇫🇷Marseille, France
HOP Nantes, Hémato, Nantes
🇫🇷Nantes, France
HOP Saint-Antoine
🇫🇷Paris Cedex 12, France
HOP Lyon Sud
🇫🇷Pierre Bénite, France
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
Med. Klinik m.S. Hämatologie und Onkologie
🇩🇪Berlin, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
Städtisches Klinikum Braunschweig gGmbH
🇩🇪Braunschweig, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt/Main, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
🇩🇪Göttingen, Germany
Martin-Luther-Universität Halle-Wittenberg
🇩🇪Halle (Saale), Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Marburg, Germany
General Hospital of Athens "G. Gennimatas"
🇬🇷Athens, Greece
Schwarzwald-Baar Klinikum
🇩🇪Villingen-Schwenningen, Germany
Robert-Bosch-Krankenhaus GmbH
🇩🇪Stuttgart, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
University of Patras Medical School
🇬🇷Patras, Greece
General Hospital of Athens "Laiko"
🇬🇷Athens, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloniki, Greece
Semmelweis University
🇭🇺Budapest, Hungary
Universitätsklinikum Münster
🇩🇪Münster, Germany
Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology
🇭🇺Gyor, Hungary
A.O. Spedali Civili di Brescia
🇮🇹Brescia, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
AO Città della Salute e della
🇮🇹Torino, Italy
National Hospital Organization Nagoya Medical Center
🇯🇵Aichi, Nagoya, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Aichi, Nagoya, Japan
Akita University Hospital
🇯🇵Akita, Akita, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Kobe University Hospital
🇯🇵Hyogo, Kobe, Japan
Osaka City University Hospital
🇯🇵Osaka, Osaka, Japan
Tokai University Hospital
🇯🇵Kanagawa, Isehara, Japan
Yokohama City University Medical Center
🇯🇵Kanagawa, Yokohama, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Nagasaki, Japan
Kurashiki Central Hospital
🇯🇵Okayama, Kurashiki, Japan
Okayama University Hospital
🇯🇵Okayama, Okayama, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
NTT Medical Center Tokyo
🇯🇵Tokyo, Sinagawa-ku, Japan
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Reg. Specialist Hospital of M. Kopernik, Dept. Haematology
🇵🇱Lodz, Poland
Centro Hospitalar Universitário São João,EPE
🇵🇹Porto, Portugal
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
🇷🇺Moscow, Russian Federation
Regional Clinical Hospital 'The Badge of Honor Order'
🇷🇺Irkutsk, Russian Federation
Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology
🇷🇺Nizhniy Novgorod, Russian Federation
Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2
🇷🇺St. Petersburg, Russian Federation
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Netcare Pretoria East Hospital
🇿🇦Moreleta Park, Pretoria, South Africa
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
UZ Leuven
🇧🇪Leuven, Belgium
Haine-St-Paul - HOSP Jolimont
🇧🇪Haine-Saint-Paul, Belgium
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium