Trial record 1 of 1 for:    1230.14
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01721876
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Last Update Posted : April 13, 2018
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: placebo Drug: volasertib Drug: low dose cytarabine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 : December 31, 2019

Arm Intervention/treatment
Experimental: Volasertib + low dose cytarabine Drug: volasertib
'Investigational Medicinal Product
Drug: low dose cytarabine
background medication
Placebo Comparator: PLACEBO + low dose cytarabine Drug: placebo
Drug: low dose cytarabine
background medication

Primary Outcome Measures :
  1. Complete Remission (CR) [ Time Frame: 4 years ]
  2. Complete remission with incomplete blood count recovery (CRi) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 4 years ]
  2. Event-free survival (EFS) [ Time Frame: 4 years ]
  3. Relapse-free survival (RFS) [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Age >= 65years.
  2. Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
  3. 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.
  4. 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).
  5. Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
  6. Eastern co-operative oncology group (ECOG) performance score <= 2 at screening.
  7. Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion criteria:

  1. 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.
  2. Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
  3. Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
  4. 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).
  5. Hypersensitivity to one of the trial drugs or the excipients.
  6. 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.
  7. 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.
  8. Total bilirubin > 3 x upper limit of normal (ULN).
  9. Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
  10. Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
  11. HIV infection.
  12. Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
  13. 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.
  14. Known or suspected active alcohol or drug abuse.
  15. Patient unable to comply with the protocol, in the opinion of the investigator.
  16. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01721876

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United States, California
University of California
Los Angeles, California, United States, 90095-1678
United States, Minnesota
St. Luke's Hospital Association of Duluth, Inc.
Duluth, Minnesota, United States, 55805
United States, Tennessee
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Fundacion COIR
Mendoza, Argentina, M5500AYB
Hospital Central de Salud Zenón Santillan
San Miguel de Tucumán, Argentina, T4000HXU
LKH-Univ. Klinikum Graz
Graz, Austria, 8036
LKH Leoben
Leoben, Austria, 8700
Hospital Hietzing
Wien, Austria, 1130
AZ Sint-Jan Brugge
Brugge, Belgium, 8000
Brussels - UNIV St-Luc
Bruxelles, Belgium, 1200
Haine-St-Paul - HOSP Jolimont
Haine-Saint-Paul, Belgium, 7100
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium, 3500
UZ Leuven
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
Roeselare - HOSP AZ Delta
Roeselare, Belgium, 8800
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, Belgium, 5530
Hospital Amaral Carvalho
Jau, Brazil, 17210-080
Hospital Mãe de Deus
Porto Alegre, Brazil, 90470-340
H.C.da Fac. de Medicina de Ribeirao Preto
Ribeirao Preto, Brazil, 14048-900
Canada, Alberta
Univerity of Alberta, Clinical Sciences Building
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Migration Data
Hopital Maisonneuve Rosemont Polyclinique/Recherche Clinique
Montreal, Migration Data, Canada, H1T 2M4
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Hospital Hradec Kralove
Hradec Kralove, Czechia, 500 05
University Hospital Plzen, Plzen-Lochotin
Plzen - Lochotin, Czechia, 304 60
Univ. Hospital Kralovske Vinohrady
Praha 10, Czechia, 100 34
Meilahden sairaala
Helsinki, Finland, 00290
TYKS, Sisätautien klinikka
Turku, Finland, 20521
HOP Amiens, Hémato, Amiens
Amiens Cedex 1, France, 80054
HOP Côte de Nacre
Caen, France, 14000
HOP Nord Michallon
La Tronche, France, 38700
HOP André Mignot
Le Chesnay cedex, France, 78157
HOP Dupuytren
Limoges Cedex 1, France, 87042
INS Paoli-Calmettes
Marseille, France, 13273
HOP Nantes, Hémato, Nantes
Nantes, France, 44000
HOP Saint-Antoine
Paris Cedex 12, France, 75012
HOP Haut-Lévêque
Pessac cedex, France, 33604
HOP Lyon Sud
Pierre Bénite, France, 69495
HOP Pontchaillou
Rennes Cedex 9, France, 35033
INS Universitaire du Cancer
Toulouse, France, 31059
Kommunalunternehmen Klinikum Augsburg
Augsburg, Germany, 86156
Med. Klinik m.S. Hämatologie und Onkologie
Berlin, Germany, 13353
Klinikum Braunschweig
Braunschweig, Germany, 38114
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45147
Universitätsklinikum Frankfurt
Frankfurt/Main, Germany, 60590
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany, 37075
Martin-Luther-Universität Halle-Wittenberg
Halle (Saale), Germany, 06120
II. Medizinische Klinik und Poliklinik
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Universitätsklinikum Gießen und Marburg GmbH
Marburg, Germany, 35043
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Universitätsklinikum Münster
Münster, Germany, 48149
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Robert-Bosch-Krankenhaus GmbH
Stuttgart, Germany, 70376
Universitätsklinikum Ulm
Ulm, Germany, 89081
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, Germany, 78052
General Hospital of Athens "G. Gennimatas"
Athens, Greece, 115 27
General Hospital of Athens "Laiko"
Athens, Greece, 11526
Univ. Gen. Hosp. of Ioannina
Ioannina, Greece, 45 500
University Hospital of Patras
Patras, Greece, 26504
General Hospital "Papanikolaou"
Thessaloniki, Greece, 57010
Semmelweis University, 1st Dept. Internal Medicine
Budapest, Hungary, 1083
Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology
Gyor, Hungary, 9024
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
Szeged, Hungary, 6725
St. John Medical College and hospital
Bangalore, India, 560034
Tata Memorial Hospital
Mumbai, India, 400012
A.O. Spedali Civili di Brescia
Brescia, Italy, 25123
ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy, 20162
Ospedale Molinette, AO Città della Salute e della
Torino, Italy, 10126
National Hospital Organization Nagoya Medical Center
Aichi, Nagoya, Japan, 460-0001
Japanese Red Cross Nagoya Daini Hospital
Aichi, Nagoya, Japan, 466-8650
Akita University Hospital
Akita, Akita, Japan, 010-8543
University of Fukui Hospital
Fukui, Yoshida-gun, Japan, 910-1193
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Kobe University Hospital
Hyogo, Kobe, Japan, 650-0017
Tokai University Hospital
Kanagawa, Isehara, Japan, 259-1193
Yokohama City University Medical Center
Kanagawa, Yokohama, Japan, 232-0024
Tohoku University Hospital
Miyagi, Sendai, Japan, 980-8547
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan, 852-8523
Kurashiki Central Hospital
Okayama, Kurashiki, Japan, 710-8602
Okayama University Hospital
Okayama, Okayama, Japan, 700-8558
Osaka City University Hospital
Osaka, Osaka, Japan, 545-8586
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
NTT Medical Center Tokyo
Tokyo, Sinagawa-ku, Japan, 141-8625
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Korea, Republic of, 519-763
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 06591
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Mexico, 64460
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Haukeland Universitetssykehus
Bergen, Norway, N-5021
Sykehuset Østfold Kalnes
Grålum, Norway, N-1714
Reg. Specialist Hospital of M. Kopernik, Dept. Haematology
Lodz, Poland, 93-510
City Hospital Torun, Department of Hematology
Torun, Poland, 87-100
CHLN, EPE - Hospital de Santa Maria
Lisboa, Portugal, 1649-035
H. Santo António - Centro Hospitalar do Porto
Porto, Portugal, 4099-001
IPO Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Centro Hospitalar São João,EPE
Porto, Portugal, 4202-451
Russian Federation
Regional Clinical Hospital 'The Badge of Honor Order'
Irkutsk, Russian Federation, 664079
FSBSI "N.N Blokhin Medical Research Center of Oncology"
Moscow, Russian Federation, 115478
Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology
Nizhniy Novgorod, Russian Federation, 603126
Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2
St. Petersburg, Russian Federation, 194291
South Africa
Netcare Pretoria East Hospital
Moreleta Park, Pretoria, South Africa, 0044
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Politècnic La Fe
Valencia, Spain, 46009
Chang-Hua Christian Hospital
ChangHua, Taiwan, 500
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT01721876     History of Changes
Other Study ID Numbers: 1230.14
2012-002487-27 ( EudraCT Number )
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs