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Leukemia, Myeloid, AcutePhase 3NCT01721876

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 3 study testing Volasertib and Cytarabine in people with Leukemia, Myeloid, Acute, run by Boehringer Ingelheim at 122 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Volasertib and Cytarabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
666 participants
Where
122 sitesin 25 countries
Study dates
29 Jan 2013to 28 May 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

122 sites in 25 countries.

122 sites in 25 countries

Germany20 sites

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Med. Klinik m.S. Hämatologie und Onkologie

    Berlin, 13353

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45147

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78052

Other trials in Germany

Japan15 sites

  • National Hospital Organization Nagoya Medical Center

    Aichi, Nagoya, 460-0001

  • Japanese Red Cross Nagoya Daini Hospital

    Aichi, Nagoya, 466-8650

  • Akita University Hospital

    Akita, Akita, 010-8543

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017

  • Tokai University Hospital

    Kanagawa, Isehara, 259-1193

  • Yokohama City University Medical Center

    Kanagawa, Yokohama, 232-0024

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8547

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8523

  • Kurashiki Central Hospital

    Okayama, Kurashiki, 710-8602

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • NTT Medical Center Tokyo

    Tokyo, Sinagawa-ku, 141-8625

Other trials in Japan

France12 sites

  • HOP Amiens-Picardie Sud

    Amiens, 80054

  • HOP Côte de Nacre

    Caen, 14000

  • HOP Michallon

    La Tronche, 38700

  • HOP André Mignot

    Le Chesnay, 78157

  • HOP Dupuytren 1

    Limoges, 87042

  • INS Paoli-Calmettes

    Marseille, 13273

  • HOP Nantes, Hémato, Nantes

    Nantes, 44000

  • HOP Saint-Antoine

    Paris, 75012

  • HOP Haut-Lévêque

    Pessac, 33604

  • HOP Lyon Sud

    Pierre-Bénite, 69495

  • HOP Pontchaillou

    Rennes, 35033

  • INS Universitaire du Cancer

    Toulouse, 31059

Other trials in France

Belgium8 sites

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • Brussels - UNIV Saint-Luc

    Brussels, 1200

  • Haine-St-Paul - HOSP Jolimont

    Haine-Saint-Paul, 7100

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800

  • Yvoir - UNIV UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Spain8 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital La Paz

    Madrid, 28046

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Politècnic La Fe

    Valencia, 46009

Other trials in Spain

South Korea6 sites

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-763

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 06591

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Canada5 sites

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2G3

  • Maisonneuve-Rosemont Hospital

    Montreal, Migration Data, H1T 2M4

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Greece5 sites

  • General Hospital of Athens "G. Gennimatas"

    Athens, 115 27

  • General Hospital of Athens "Laiko"

    Athens, 11526

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

  • University of Patras Medical School

    Pátrai, 26504

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

United States4 sites

  • St. Luke's Hospital Association of Duluth, Inc.

    Duluth, Minnesota, 55805

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California

    Los Angeles, California, 90095-1678

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

Other trials in United States

Portugal4 sites

  • CHULN, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

    Porto, 4099-001

  • IPO Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4202-451

Other trials in Portugal

Russia4 sites

  • Regional Clinical Hospital 'The Badge of Honor Order'

    Irkutsk, 664079

  • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

    Moscow, 115478

  • Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology

    Nizhny Novgorod, 603126

  • Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2

    Saint Petersburg, 194291

Other trials in Russia

Austria3 sites

  • LKH-Univ. Hospital Graz

    Graz, 8036

  • LKH Leoben

    Leoben, 8700

  • Hospital Hietzing

    Vienna, 1130

Other trials in Austria

Brazil3 sites

  • Hospital Doutor Amaral Carvalho

    Jaú, 17210-080

  • Hospital Mãe de Deus

    Porto Alegre, 90470-340

  • H.C.da Fac. de Medicina de Ribeirao Preto

    Ribeirão Preto, 14048-900

Other trials in Brazil

Czechia3 sites

  • Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Plzen, Plzen-Lochotin

    Plzen - Lochotin, 304 60

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34

Other trials in Czechia

Hungary3 sites

  • Semmelweis University

    Budapest, 1083

  • Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology

    Győr, 9024

  • Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

    Szeged, 6725

Other trials in Hungary

Italy3 sites

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • AO Città della Salute e della

    Torino, 10126

Other trials in Italy

Taiwan3 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 112

Other trials in Taiwan

Argentina2 sites

  • Fundacion COIR

    Mendoza, M5500AYB

  • Hospital Central de Salud Zenón Santillan

    San Miguel de Tucumán, T4000HXU

Other trials in Argentina

Finland2 sites

  • Meilahden sairaala

    Helsinki, 00290

  • TYKS, Sisätautien klinikka

    Turku, 20521

Other trials in Finland

India2 sites

  • St. John Medical College and hospital

    Bangalore, 560034

  • Tata Memorial Hospital

    Mumbai, 400012

Other trials in India

Norway2 sites

  • Haukeland Universitetssykehus

    Bergen, N-5021

  • Sykehuset Østfold Kalnes

    Grålum, N-1714

Other trials in Norway

Poland2 sites

  • Reg. Specialist Hospital of M. Kopernik, Dept. Haematology

    Lodz, 93-510

  • City Hospital Torun, Department of Hematology

    Torun, 87-100

Other trials in Poland

Mexico1 site

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Netherlands1 site

  • Amsterdam UMC Locatie VUMC

    Amsterdam, 1081 HV

Other trials in Netherlands

South Africa1 site

  • Netcare Pretoria East Hospital

    Moreleta Park, Pretoria, 0044

Other trials in South Africa

About this study

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

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

Being tested
Placebo, Volasertib, Cytarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo matching Volasertib

  • VolasertibDrug

    Volasertib

  • CytarabineDrug

    Cytarabine

Study groups in NCT01721876
Study groupRoleWhat they receive
Volasertib and CytarabineExperimentalNot described
Receives: Drug: Volasertib; Drug: Cytarabine
Placebo and CytarabinePlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: From randomization until death due to any cause, up to 1557 days.

  2. 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.

    Measured: From randomization until disease progression or relapse or death from any cause, up to 1557 days.

  3. 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.

    Measured: From randomization until disease progression or relapse or death from any cause, up to 1557 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2012 (estimated)
  2. Study start29 Jan 2013
  3. Primary completion12 Aug 2014
  4. Study completion28 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01721876
Sponsor's protocol ID
1230.14
Other IDs
2012-002487-27
Status last verified
Feb 2023
First submitted
2 Nov 2012
Last updated
8 Feb 2023
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 34646387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Volasertib and Cytarabine in people with Leukemia, Myeloid, Acute, run by Boehringer Ingelheim at 122 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in Germany, Japan, France, Belgium, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (OR) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721876, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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