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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01721876
First received: November 2, 2012
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
Leukemia, Myeloid, Acute
Drug: placebo
Drug: volasertib
Drug: low dose cytarabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Complete Remission (CR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Complete remission with incomplete blood count recovery (CRi) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Event-free survival (EFS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Relapse-free survival (RFS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 666
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Volasertib + low dose cytarabine Drug: volasertib
'Investigational Medicinal Product
Drug: low dose cytarabine
background medication
Placebo Comparator: PLACEBO + low dose cytarabine Drug: placebo
comparator
Drug: low dose cytarabine
background medication

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721876

  Hide Study Locations
Locations
United States, California
1230.14.10012 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, Minnesota
1230.14.10006 Boehringer Ingelheim Investigational Site
Duluth, Minnesota, United States
United States, Tennessee
1230.14.10015 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
United States, Texas
1230.14.10001 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Argentina
1230.14.54002 Boehringer Ingelheim Investigational Site
Mendoza, Argentina
1230.14.54005 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán, Argentina
Austria
1230.14.43001 Boehringer Ingelheim Investigational Site
Graz, Austria
1230.14.43003 Boehringer Ingelheim Investigational Site
Leoben, Austria
1230.14.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1230.14.32002 Boehringer Ingelheim Investigational Site
Brugge, Belgium
1230.14.32001 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1230.14.32007 Boehringer Ingelheim Investigational Site
Haine-Saint-Paul, Belgium
1230.14.32003 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
1230.14.32005 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1230.14.32006 Boehringer Ingelheim Investigational Site
Liège, Belgium
1230.14.32008 Boehringer Ingelheim Investigational Site
Roeselare, Belgium
1230.14.32004 Boehringer Ingelheim Investigational Site
Yvoir, Belgium
Brazil
1230.14.55003 Boehringer Ingelheim Investigational Site
Jau, Brazil
1230.14.55001 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1230.14.55002 Boehringer Ingelheim Investigational Site
Ribeirao Preto, Brazil
Canada, Alberta
1230.14.11005 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1230.14.11004 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Ontario
1230.14.11001 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1230.14.11002 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1230.14.11003 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Czech Republic
1230.14.42004 Boehringer Ingelheim Investigational Site
Hradec Kralove, Czech Republic
1230.14.42003 Boehringer Ingelheim Investigational Site
Plzen - Lochotin, Czech Republic
1230.14.42002 Boehringer Ingelheim Investigational Site
Praha 10, Czech Republic
Finland
1230.14.35801 Boehringer Ingelheim Investigational Site
Helsinki, Finland
1230.14.35802 Boehringer Ingelheim Investigational Site
Turku, Finland
France
1230.14.33011 Boehringer Ingelheim Investigational Site
Amiens Cedex 1, France
1230.14.33003 Boehringer Ingelheim Investigational Site
Angers Cedex 09, France
1230.14.33012 Boehringer Ingelheim Investigational Site
Caen, France
1230.14.33002 Boehringer Ingelheim Investigational Site
La Tronche, France
1230.14.33001 Boehringer Ingelheim Investigational Site
Le Chesnay cedex, France
1230.14.33007 Boehringer Ingelheim Investigational Site
Limoges Cedex 1, France
1230.14.33008 Boehringer Ingelheim Investigational Site
Marseille Cedex 09, France
1230.14.33015 Boehringer Ingelheim Investigational Site
Nantes, France
1230.14.33004 Boehringer Ingelheim Investigational Site
Paris Cedex 12, France
1230.14.33005 Boehringer Ingelheim Investigational Site
Pessac cedex, France
1230.14.33006 Boehringer Ingelheim Investigational Site
Pierre Bénite Cedex, France
1230.14.33013 Boehringer Ingelheim Investigational Site
Rennes Cedex 9, France
1230.14.33014 Boehringer Ingelheim Investigational Site
Toulouse Cedex 9, France
Germany
1230.14.49012 Boehringer Ingelheim Investigational Site
Augsburg, Germany
1230.14.49005 Boehringer Ingelheim Investigational Site
Berlin, Germany
1230.14.49022 Boehringer Ingelheim Investigational Site
Braunschweig, Germany
1230.14.49015 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1230.14.49010 Boehringer Ingelheim Investigational Site
Essen, Germany
1230.14.49003 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1230.14.49020 Boehringer Ingelheim Investigational Site
Göttingen, Germany
1230.14.49023 Boehringer Ingelheim Investigational Site
Halle (Saale), Germany
1230.14.49007 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1230.14.49008 Boehringer Ingelheim Investigational Site
Hannover, Germany
1230.14.49004 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1230.14.49006 Boehringer Ingelheim Investigational Site
Kiel, Germany
1230.14.49021 Boehringer Ingelheim Investigational Site
Mainz, Germany
1230.14.49018 Boehringer Ingelheim Investigational Site
Marburg, Germany
1230.14.49009 Boehringer Ingelheim Investigational Site
München, Germany
1230.14.49002 Boehringer Ingelheim Investigational Site
Münster, Germany
1230.14.49016 Boehringer Ingelheim Investigational Site
Regensburg, Germany
1230.14.49014 Boehringer Ingelheim Investigational Site
Stuttgart, Germany
1230.14.49001 Boehringer Ingelheim Investigational Site
Ulm, Germany
1230.14.49011 Boehringer Ingelheim Investigational Site
Villingen-Schwenningen, Germany
Greece
1230.14.30001 Boehringer Ingelheim Investigational Site
Athens, Greece
1230.14.30005 Boehringer Ingelheim Investigational Site
Athens, Greece
1230.14.30004 Boehringer Ingelheim Investigational Site
Ioannina, Greece
1230.14.30002 Boehringer Ingelheim Investigational Site
Patras, Greece
1230.14.30003 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Hungary
1230.14.36002 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1230.14.36003 Boehringer Ingelheim Investigational Site
Gyor, Hungary
1230.14.36001 Boehringer Ingelheim Investigational Site
Szeged, Hungary
India
1230.14.91003 Boehringer Ingelheim Investigational Site
Bangalore, India
Italy
1230.14.39004 Boehringer Ingelheim Investigational Site
Brescia, Italy
1230.14.39001 Boehringer Ingelheim Investigational Site
Milano, Italy
1230.14.39003 Boehringer Ingelheim Investigational Site
Torino, Italy
Japan
1230.14.81009 Boehringer Ingelheim Investigational Site
Abeno-ku, Osaka, Japan
1230.14.81016 Boehringer Ingelheim Investigational Site
Aichi, Nagoya, Japan
1230.14.81014 Boehringer Ingelheim Investigational Site
Akita, Akita, Japan
1230.14.81003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1230.14.81007 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
1230.14.81010 Boehringer Ingelheim Investigational Site
Isehara, Kanagawa, Japan
1230.14.81013 Boehringer Ingelheim Investigational Site
Kobe, Hyogo, Japan
1230.14.81008 Boehringer Ingelheim Investigational Site
Nagasaki, Nagasaki, Japan
1230.14.81006 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1230.14.81018 Boehringer Ingelheim Investigational Site
Okayama, Kurashiki, Japan
1230.14.81012 Boehringer Ingelheim Investigational Site
Okayama,Okayama, Japan
1230.14.81001 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1230.14.81004 Boehringer Ingelheim Investigational Site
Sinagawa-ku, Tokyo, Japan
1230.14.81011 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
1230.14.81005 Boehringer Ingelheim Investigational Site
Yoshida-gun, Fukui, Japan
Korea, Republic of
1230.14.82006 Boehringer Ingelheim Investigational Site
Hwasun, Korea, Republic of
1230.14.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1230.14.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1230.14.82003 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1230.14.82004 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1230.14.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Mexico
1230.14.52001 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
Netherlands
1230.14.31001 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
Norway
1230.14.47001 Boehringer Ingelheim Investigational Site
Bergen, Norway
1230.14.47003 Boehringer Ingelheim Investigational Site
Fredrikstad, Norway
Poland
1230.14.48001 Boehringer Ingelheim Investigational Site
Lodz, Poland
1230.14.48003 Boehringer Ingelheim Investigational Site
Torun, Poland
Portugal
1230.14.35003 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1230.14.35001 Boehringer Ingelheim Investigational Site
Porto, Portugal
1230.14.35004 Boehringer Ingelheim Investigational Site
Porto, Portugal
1230.14.35005 Boehringer Ingelheim Investigational Site
Porto, Portugal
Russian Federation
1230.14.07007 Boehringer Ingelheim Investigational Site
Irkutsk, Russian Federation
1230.14.07002 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1230.14.07004 Boehringer Ingelheim Investigational Site
Nizhniy Novgorod, Russian Federation
1230.14.07006 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
South Africa
1230.14.27003 Boehringer Ingelheim Investigational Site
Moreleta Park, Pretoria, South Africa
Spain
1230.14.34003 Boehringer Ingelheim Investigational Site
Badalona, Spain
1230.14.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1230.14.34004 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1230.14.34008 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1230.14.34005 Boehringer Ingelheim Investigational Site
Madrid, Spain
1230.14.34006 Boehringer Ingelheim Investigational Site
Madrid, Spain
1230.14.34007 Boehringer Ingelheim Investigational Site
Salamanca, Spain
1230.14.34002 Boehringer Ingelheim Investigational Site
Valencia, Spain
Taiwan
1230.14.88603 Boehringer Ingelheim Investigational Site
ChangHua, Taiwan
1230.14.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1230.14.88602 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01721876     History of Changes
Other Study ID Numbers: 1230.14, 2012-002487-27
Study First Received: November 2, 2012
Last Updated: July 27, 2015
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Medical Ethics Review Committee (METC)
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 30, 2015