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
2 other identifiers
interventional
666
25 countries
122
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
Longer than P75 for phase_3
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedStudy Start
First participant enrolled
January 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2021
CompletedResults Posted
Study results publicly available
November 19, 2021
CompletedFebruary 8, 2023
February 1, 2023
1.5 years
November 2, 2012
September 9, 2021
February 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
Secondary Outcomes (3)
Overall Survival (OS)
From randomization until death due to any cause, up to 1557 days.
Event-free Survival (EFS)
From randomization until disease progression or relapse or death from any cause, up to 1557 days.
Relapse-free Survival (RFS)
From randomization until disease progression or relapse or death from any cause, up to 1557 days.
Study Arms (2)
Volasertib and Cytarabine
EXPERIMENTALPlacebo and Cytarabine
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age \>= 65years.
- Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
- Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.
- Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions).
- Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
- Eastern co-operative oncology group (ECOG) performance score \<= 2 at screening.
- Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.
You may not qualify if:
- Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed.
- Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
- Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
- Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator´s judgement is sufficient).
- Hypersensitivity to one of the trial drugs or the excipients.
- Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
- Corrected QT interval according to Fridericia (QTcF) prolongation \> 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
- Total bilirubin \> 3 x upper limit of normal (ULN).
- Creatinine clearance (CLcr) \< 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
- Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
- HIV infection.
- Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
- Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results.
- Known or suspected active alcohol or drug abuse.
- Patient unable to comply with the protocol, in the opinion of the investigator.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
University of California
Los Angeles, California, 90095-1678, United States
St. Luke's Hospital Association of Duluth, Inc.
Duluth, Minnesota, 55805, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fundacion COIR
Mendoza, M5500AYB, Argentina
Hospital Central de Salud Zenón Santillan
San Miguel de Tucumán, T4000HXU, Argentina
LKH-Univ. Hospital Graz
Graz, 8036, Austria
LKH Leoben
Leoben, 8700, Austria
Hospital Hietzing
Vienna, 1130, Austria
AZ Sint-Jan Brugge
Bruges, 8000, Belgium
Brussels - UNIV Saint-Luc
Brussels, 1200, Belgium
Haine-St-Paul - HOSP Jolimont
Haine-Saint-Paul, 7100, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Roeselare - HOSP AZ Delta
Roeselare, 8800, Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530, Belgium
Hospital Doutor Amaral Carvalho
Jaú, 17210-080, Brazil
Hospital Mãe de Deus
Porto Alegre, 90470-340, Brazil
H.C.da Fac. de Medicina de Ribeirao Preto
Ribeirão Preto, 14048-900, Brazil
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2G3, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Maisonneuve-Rosemont Hospital
Montreal, Migration Data, H1T 2M4, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Plzen, Plzen-Lochotin
Plzen - Lochotin, 304 60, Czechia
Univ. Hospital Kralovske Vinohrady
Prague, 100 34, Czechia
Meilahden sairaala
Helsinki, 00290, Finland
TYKS, Sisätautien klinikka
Turku, 20521, Finland
HOP Amiens-Picardie Sud
Amiens, 80054, France
HOP Côte de Nacre
Caen, 14000, France
HOP Michallon
La Tronche, 38700, France
HOP André Mignot
Le Chesnay, 78157, France
HOP Dupuytren 1
Limoges, 87042, France
INS Paoli-Calmettes
Marseille, 13273, France
HOP Nantes, Hémato, Nantes
Nantes, 44000, France
HOP Saint-Antoine
Paris, 75012, France
HOP Haut-Lévêque
Pessac, 33604, France
HOP Lyon Sud
Pierre-Bénite, 69495, France
HOP Pontchaillou
Rennes, 35033, France
INS Universitaire du Cancer
Toulouse, 31059, France
Universitätsklinikum Augsburg
Augsburg, 86156, Germany
Med. Klinik m.S. Hämatologie und Onkologie
Berlin, 13353, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45147, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, 35043, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, 78052, Germany
General Hospital of Athens "G. Gennimatas"
Athens, 115 27, Greece
General Hospital of Athens "Laiko"
Athens, 11526, Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500, Greece
University of Patras Medical School
Pátrai, 26504, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010, Greece
Semmelweis University
Budapest, 1083, Hungary
Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology
Győr, 9024, Hungary
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
Szeged, 6725, Hungary
St. John Medical College and hospital
Bangalore, 560034, India
Tata Memorial Hospital
Mumbai, 400012, India
A.O. Spedali Civili di Brescia
Brescia, 25123, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
AO Città della Salute e della
Torino, 10126, Italy
National Hospital Organization Nagoya Medical Center
Aichi, Nagoya, 460-0001, Japan
Japanese Red Cross Nagoya Daini Hospital
Aichi, Nagoya, 466-8650, Japan
Akita University Hospital
Akita, Akita, 010-8543, Japan
University of Fukui Hospital
Fukui, Yoshida-gun, 910-1193, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kobe University Hospital
Hyogo, Kobe, 650-0017, Japan
Tokai University Hospital
Kanagawa, Isehara, 259-1193, Japan
Yokohama City University Medical Center
Kanagawa, Yokohama, 232-0024, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8547, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8523, Japan
Kurashiki Central Hospital
Okayama, Kurashiki, 710-8602, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
NTT Medical Center Tokyo
Tokyo, Sinagawa-ku, 141-8625, Japan
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Amsterdam UMC Locatie VUMC
Amsterdam, 1081 HV, Netherlands
Haukeland Universitetssykehus
Bergen, N-5021, Norway
Sykehuset Østfold Kalnes
Grålum, N-1714, Norway
Reg. Specialist Hospital of M. Kopernik, Dept. Haematology
Lodz, 93-510, Poland
City Hospital Torun, Department of Hematology
Torun, 87-100, Poland
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
Porto, 4099-001, Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4202-451, Portugal
Regional Clinical Hospital 'The Badge of Honor Order'
Irkutsk, 664079, Russia
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
Moscow, 115478, Russia
Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology
Nizhny Novgorod, 603126, Russia
Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2
Saint Petersburg, 194291, Russia
Netcare Pretoria East Hospital
Moreleta Park, Pretoria, 0044, South Africa
Chonnam National University Hwasun Hospital
Hwasun, 519-763, South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Politècnic La Fe
Valencia, 46009, Spain
Chang-Hua Christian Hospital
Changhua, 500, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 112, Taiwan
Related Publications (1)
Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.
PMID: 34646387DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The final analysis presented in this report was conducted after 574 Overall Survival events had occurred. The final analysis was exploratory and descriptive.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2012
First Posted
November 6, 2012
Study Start
January 29, 2013
Primary Completion
August 12, 2014
Study Completion
May 28, 2021
Last Updated
February 8, 2023
Results First Posted
November 19, 2021
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency