Observational Study of Blinatumomab

An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices

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

Study Overview

• Status: Completed
• Conditions: Blincyto Use in Routine Clinical Practice

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.

• Study Type: Observational
• Enrollment (Actual): 279

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg
  • Wien, Austria, 1140
    • Hanuschkrankenhaus
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Plzen, Czechia, 304 60
    • Fakultní nemocnice Plzen
  • Praha 2, Czechia, 128 20
    • Ustav hematologie a krevni transfuze
• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital
• France
  • Angers cedex 09, France, 49933
    • Centre Hospitalier Universitaire Dieu Angers
  • Besançon, France, 25030
    • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
  • Clamart, France, 92140
    • Hopital d Instruction des Armee
  • Clermont-Ferrand, France, 63000
    • Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
  • Créteil, France, 94010
    • Hôpital Henri Mondor
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  • Montpellier Cedex 5, France, 34295
    • Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
  • Nice cedex 3, France, 06202
    • Centre Hospitalier Universitaire de Nice
  • Paris, France, 75010
    • Hopital Saint Louis
  • Pessac Cedex, France, 33604
    • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
  • Pierre-Benite, France, 69495
    • Centre hospitalier Lyon Sud
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
  • Strasbourg, France, 67033
    • Institut De Cancerologie Strasbourg
  • Toulouse cedex 9, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Vandoeuvre les Nancy Cedex, France, 54511
    • Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum Dresden
  • Frankfurt am Main, Germany, 60590
    • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
  • Halle (Saale), Germany, 06120
    • Universitätsklinikum Halle/Saale
  • München, Germany, 80804
    • Städtisches Klinikum München GmbH
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg AöR
• Greece
  • Athens, Greece, 12462
    • Attikon University Hospital
  • Athens, Greece, 11527
    • Laiko General Hospital of Athens
  • Athens, Greece, 10676
    • Evangelismos Hospital
  • Patra, Greece, 26504
    • University Hospital of Patras
• Italy
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Catania, Italy, 95123
    • Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
  • Firenze, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • Milano, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Milano, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Modena, Italy, 41100
    • Azienda Ospedaliero Universitaria di Modena
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Pagani (SA), Italy, 84016
    • Presidio Ospedaliero Andrea Tortora
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  • Pescara, Italy, 65100
    • Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
  • Reggio Emilia, Italy, 42123
    • Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova
  • Roma, Italy, 00161
    • Azienda Ospedaliera Policlinico Umberto I
  • Torino, Italy, 10126
    • Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
  • Torino, Italy, 10128
    • Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I
  • Venezia, Italy, 30174
    • Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Krakow, Poland, 31-501
    • SPZOZ Szpital Uniwersytecki w Krakowie
  • Kraków, Poland, 31-826
    • Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
  • Poznan, Poland, 60-569
    • Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
  • Warszawa, Poland, 02-776
    • Instytut Hematologii i Transfuzjologii
  • Warszawa, Poland, 02-097
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
  • Wroclaw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
• Portugal
  • Lisboa, Portugal, 1099-023
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
  • Lisboa, Portugal, 1169-050
    • Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto EPE - Hospital de Santo Antonio
• Sweden
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
  • Bellinzona, Switzerland, 6501
    • Instituto Oncologico Della Svizzera Italiana
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Geneve, Switzerland, 1205
    • Hôpitaux Universitaires de Genève
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital
  • St Gallen, Switzerland, 9007
    • Kantonsspital St Gallen
  • Zuerich, Switzerland, 8091
    • UniversitaetsSpital Zuerich
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Northwick Park Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital, St James Institute of Oncology
  • Liverpool, United Kingdom, L7 8YA
    • Royal Liverpool University Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomews Hospital
  • London, United Kingdom, SW17 0QT
    • St Georges Hospital
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients initiating Blinatumomab; Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of first specified AEs	Time to onset of first specified AEs.	Estimated to be 100 days
Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events)	Summary of duration of specified AEs (all events and resolved/recovered events); Neurological adverse events; Opportunistic Infections	Estimated to be 100 days
Proportion of Blincyto administrations with medication errors	Proportion of Blincyto administrations with medication errors, defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient, identified through medical records. Types of medication errors will also be described; incorrect Blincyto dose administered/prepared (eg. drug concentration, device issues, treatment according to SmPC); does not include treatment related to dexamethasone.	Estimated to be 100 days
Proportion of patients with specified AEs as mentioned in description	Neurological adverse events; Opportunistic infections; Cytokine release syndrome	Estimated to be 100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with AEs as detailed in the description	Incidence of all AEs collected in this study (overall, and by severity and seriousness) occurring during blinatumomab treatment and up to 30 days after completion of treatment • Incidence of specified AEs and all AEs collected in this study among patient subgroups defined by demographic and clinical factors.	Estimated to be 100 days
Proportion of patients achieving Complete Remission overall and amongst patient sub-groups	Proportion of patients achieving Complete Remission within 2 cycles of Blincyto treatment; Complete remission - Defined as ≤ 5% bone marrow myeloblasts, platelets more than 100,000 cells per µL, and absolute neutrophil count > 1,000 cells per µL.	Estimated to be 100 days
Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups	Proportion of patients achieving CR/CRh*/CRi within 2 cycles Blincyto treatment; CR defined as ≤ 5% bone marrow blasts, platelets more than 100,000 cells per µL, and absolute neutrophil count > 1,000 cells per µL; CRh* defined as ≤ 5% bone marrow blasts, platelets more than 50,000 cells per µL, and absolute neutrophil count > 500 cells per µL; CRi defined as ≤ 5% bone marrow blasts and incomplete recovery of peripheral blood counts.	Estimated to be 100 days
Proportion of patients receiving allogeneic HSCT amongst patient sub-groups	Proportion of patients receiving allogeneic HSCT amongst patient sub-groups. Defined for the subset of subjects who achieved CR.	Estimated to be 100 days
1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups	1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups. Defined for the subset of subjects who achieved CR.	Estimated to be 100 days
Relapse-free survival (RFS) time amongst patient sub-groups	Relapse-free survival (RFS) time - defined as time from CR/CRh*/CRi until relapse (proportion of blasts in bone marrow > 5% or blasts in peripheral blood after documented CR/CRh*/CRi) or death. Defined for the subset of subjects who achieved CR.	Estimated to be 100 days
Disease Free Survival (DFS) time	Disease Free Survival time - Defined as time from initiation of Blincyto (for MRD positive patients at initiation) until date of relapse or death.	Estimated to be 100 days
Overall survival (OS) time amongst patient sub-groups	Overall survival (OS) time - defined as time from initiation of Blincyto until death.	Estimated to be 100 days
Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto	Overall and amongst patient sub-groups - Proportion of patients with minimal residual disease (MRD) among those who achieve CR/CRh*/CRi within two cycles of Blincyto treatment - hematologic MRD detected by polymerase chain reaction (PCR) (or flow cytometry) at a level of 1 x 10-4 or higher.	Estimated to be 100 days
Blincyto utilisation: Number of completed cycles		Estimated to be 100 days
Blincyto utilisation: Total number of days of administration		Estimated to be 100 days
Blincyto utilisation: Proportion of patients with dose step-up on Day 8		Day 8
Blincyto utilisation: Number of cycles initiated		Estimated to be 100 days
Blincyto utilisation: Number of bag changes		Estimated to be 100 days
Blincyto utilisation: Proportion of patients with treatment changes	Treatment changes include interruption, discontinuation, and dose reduction.	Estimated to be 100 days
Select healthcare resource use: Number of bag changes in each setting	Setting of blincyto bag changes include in the hospital, in the outpatient clinic, or at home.	Estimated to be 100 days
Select healthcare resource use: Total number of days of inpatient Blincyto treatment		Estimated to be 100 days
Select healthcare resource use: Proportion of treatment days that were inpatient		Estimated to be 100 days
Select healthcare resource use: Incidence of hospitalization not related to infusion		Estimated to be 100 days
Select healthcare resource use: Length of hospital stay not related to infusion		Estimated to be 100 days

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Blincyto
• Other Study ID Numbers: 20150136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No