Clinical trial NCT03117621: Observational Study of Blinatumomab
Official title: An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blincyto Use in Routine Clinical Practice
Keywords: Blincyto
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 279
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients receiving Blincyto at participating clinical centres after country-specific reimbursement of Blincyto in the Europe.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with specified AEs as mentioned in description
timeFrame: Estimated to be 100 days
measure: Time to onset of first specified AEs
timeFrame: Estimated to be 100 days
measure: Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events)
timeFrame: Estimated to be 100 days
measure: Proportion of Blincyto administrations with medication errors
timeFrame: Estimated to be 100 days
Secondary outcomes:
measure: Proportion of patients with AEs as detailed in the description
timeFrame: Estimated to be 100 days
measure: Proportion of patients achieving Complete Remission overall and amongst patient sub-groups
timeFrame: Estimated to be 100 days
measure: Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups
timeFrame: Estimated to be 100 days
measure: Proportion of patients receiving allogeneic HSCT amongst patient sub-groups
timeFrame: Estimated to be 100 days
measure: 1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups
timeFrame: Estimated to be 100 days
measure: Relapse-free survival (RFS) time amongst patient sub-groups
timeFrame: Estimated to be 100 days
measure: Disease Free Survival (DFS) time
timeFrame: Estimated to be 100 days
measure: Overall survival (OS) time amongst patient sub-groups
timeFrame: Estimated to be 100 days
measure: Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto
timeFrame: Estimated to be 100 days
measure: Blincyto utilisation: Number of completed cycles
timeFrame: Estimated to be 100 days
measure: Blincyto utilisation: Total number of days of administration
timeFrame: Estimated to be 100 days
measure: Blincyto utilisation: Proportion of patients with dose step-up on Day 8
timeFrame: Day 8
measure: Blincyto utilisation: Number of cycles initiated
timeFrame: Estimated to be 100 days
measure: Blincyto utilisation: Number of bag changes
timeFrame: Estimated to be 100 days
measure: Blincyto utilisation: Proportion of patients with treatment changes
timeFrame: Estimated to be 100 days
measure: Select healthcare resource use: Number of bag changes in each setting
timeFrame: Estimated to be 100 days
measure: Select healthcare resource use: Total number of days of inpatient Blincyto treatment
timeFrame: Estimated to be 100 days
measure: Select healthcare resource use: Proportion of treatment days that were inpatient
timeFrame: Estimated to be 100 days
measure: Select healthcare resource use: Incidence of hospitalization not related to infusion
timeFrame: Estimated to be 100 days
measure: Select healthcare resource use: Length of hospital stay not related to infusion
timeFrame: Estimated to be 100 days
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Hanuschkrankenhaus
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 2
country: Czechia
facility: Ustav hematologie a krevni transfuze
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Angers cedex 09
country: France
facility: Centre Hospitalier Universitaire Dieu Angers
city: Besançon
country: France
facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
city: Clamart
country: France
facility: Hopital d Instruction des Armee
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
city: Montpellier Cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
city: Nice cedex 3
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Paris
country: France
facility: Hopital Saint Louis
city: Pessac Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg
city: Toulouse cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
city: Vandoeuvre les Nancy Cedex
country: France
facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Frankfurt am Main
country: Germany
facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle/Saale
city: München
country: Germany
facility: Städtisches Klinikum München GmbH
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AoR
city: Athens
country: Greece
facility: Evangelismos Hospital
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Athens
country: Greece
facility: Attikon University Hospital
city: Patra
country: Greece
facility: University Hospital of Patras
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Pagani (SA)
country: Italy
facility: Presidio Ospedaliero Andrea Tortora
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
city: Pescara
country: Italy
facility: Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
city: Reggio Emilia
country: Italy
facility: Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I
city: Venezia
country: Italy
facility: Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
city: Poznan
country: Poland
facility: Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto EPE - Hospital de Santo Antonio
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bellinzona
country: Switzerland
facility: Instituto Oncologico Della Svizzera Italiana
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: St Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital, St James Institute of Oncology
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: London
country: United Kingdom
facility: St Georges Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: