Observational Study of Blinatumomab

NCT ID: NCT03117621

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-22

Study Completion Date

2024-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this study is to characterize the safety of Blincyto in routine clinical practice. Blincyto effectiveness, medication errors, and utilisation; and select healthcare resource use while using Blincyto will also be described. Safety and effectiveness of Blincyto in specified subgroups of patients will also be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blincyto Use in Routine Clinical Practice

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients initiating Blinatumomab

Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.

Exclusion Criteria

* Medical records of patients who have participated in Blincyto clinical trials will be excluded since their treatment will be prescribed by the study protocol unless the patient is receiving new Blincyto treatment outside the clinical trial.
* Medical records of patients participating in other Amgen non-interventional prospective studies in which safety endpoints are collected will be excluded.
* Medical records of patients who have received Blincyto via an expanded access/compassionate use program will be excluded.
* In countries where patient informed consent is required for access to their medical records, any patient who does not provide informed consent will be excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ordensklinikum Linz Elisabethinen

Linz, , Austria

Site Status

Landeskrankenhaus Salzburg

Salzburg, , Austria

Site Status

Hanuschkrankenhaus

Vienna, , Austria

Site Status

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status

Fakultni nemocnice Plzen

Pilsen, , Czechia

Site Status

Ustav hematologie a krevni transfuze

Prague, , Czechia

Site Status

Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Centre Hospitalier Universitaire Dieu Angers

Angers, , France

Site Status

Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

Besançon, , France

Site Status

Hopital d Instruction des Armee

Clamart, , France

Site Status

Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing

Clermont-Ferrand, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

Lille, , France

Site Status

Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

Montpellier, , France

Site Status

Centre Hospitalier Universitaire de Nice

Nice, , France

Site Status

Hopital Saint Louis

Paris, , France

Site Status

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

Pessac, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

Poitiers, , France

Site Status

Institut de Cancerologie Strasbourg

Strasbourg, , France

Site Status

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, , France

Site Status

Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Universitätsklinikum Dresden

Dresden, , Germany

Site Status

Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, , Germany

Site Status

Universitätsklinikum Halle/Saale

Halle, , Germany

Site Status

Städtisches Klinikum München GmbH

München, , Germany

Site Status

Klinikum Oldenburg AoR

Oldenburg, , Germany

Site Status

Evangelismos Hospital

Athens, , Greece

Site Status

Laiko General Hospital of Athens

Athens, , Greece

Site Status

Attikon University Hospital

Athens, , Greece

Site Status

University Hospital of Patras

Pátrai, , Greece

Site Status

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, , Italy

Site Status

Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

Bologna, , Italy

Site Status

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, , Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

Catania, , Italy

Site Status

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status

Ospedale Policlinico San Martino IRCCS

Genova, , Italy

Site Status

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria di Modena

Modena, , Italy

Site Status

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Site Status

Presidio Ospedaliero Andrea Tortora

Pagani (SA), , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

Perugia, , Italy

Site Status

Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

Pescara, , Italy

Site Status

Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Azienda Ospedaliera Policlinico Umberto I

Roma, , Italy

Site Status

Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

Torino, , Italy

Site Status

Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I

Torino, , Italy

Site Status

Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

Venezia, , Italy

Site Status

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Site Status

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Site Status

Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

Krakow, , Poland

Site Status

Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

Poznan, , Poland

Site Status

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, , Poland

Site Status

Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

Site Status

Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , Poland

Site Status

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, , Portugal

Site Status

Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos

Lisbon, , Portugal

Site Status

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

Lisbon, , Portugal

Site Status

Centro Hospitalar do Porto EPE - Hospital de Santo Antonio

Porto, , Portugal

Site Status

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status

Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Universitaetsspital Basel

Basel, , Switzerland

Site Status

Instituto Oncologico Della Svizzera Italiana

Bellinzona, , Switzerland

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Hopitaux Universitaires de Geneve

Geneva, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status

Kantonsspital St Gallen

Sankt Gallen, , Switzerland

Site Status

Universitaetsspital Zuerich

Zurich, , Switzerland

Site Status

Northwick Park Hospital

Harrow, , United Kingdom

Site Status

St James University Hospital, St James Institute of Oncology

Leeds, , United Kingdom

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

St Bartholomews Hospital

London, , United Kingdom

Site Status

St Georges Hospital

London, , United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Czechia Finland France Germany Greece Italy Netherlands Poland Portugal Sweden Switzerland United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20150136

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase III Study on HMPL-523 for Treatment of ITP
NCT05029635 ACTIVE_NOT_RECRUITING PHASE3