Blincyto Use in Routine Clinical PracticeNCT03117621
Observational Study of Blinatumomab
An observational study of Blincyto Use in Routine Clinical Practice, run by Amgen at 80 sites in 13 countries.
Trial summary
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blincyto Use in Routine Clinical Practice
- How many people
- 279 participants
- Where
- 80 sitesin 13 countries
- Study dates
- 22 Mar 2017to 20 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include patients receiving Blincyto at participating clinical centres after country-specific reimbursement of Blincyto in the Europe.
Who may be able to join
- Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.
Who cannot join
- 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.
Trial locations and contacts
80 sites in 13 countries.
80 sites in 13 countries
Italy19 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico
Catania, 95123
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Ospedale Policlinico San Martino IRCCS
Genova, 16132
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliero Universitaria di Modena
Modena, 41100
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Presidio Ospedaliero Andrea Tortora
Pagani (SA), 84016
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156
Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
Pescara, 65100
Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino, 10126
Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I
Torino, 10128
Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
Venezia, 30174
France15 sites
Centre Hospitalier Universitaire Dieu Angers
Angers, 49933
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
Besançon, 25030
Hopital d Instruction des Armee
Clamart, 92140
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
Clermont-Ferrand, 63000
Hôpital Henri Mondor
Créteil, 94010
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, 59037
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier, 34295
Centre Hospitalier Universitaire de Nice
Nice, 06202
Hopital Saint Louis
Paris, 75010
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, 86000
Institut de Cancerologie Strasbourg
Strasbourg, 67033
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, 31059
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54511
Switzerland9 sites
Kantonsspital Aarau
Aarau, 5001
Universitaetsspital Basel
Basel, 4031
Instituto Oncologico Della Svizzera Italiana
Bellinzona, 6501
Inselspital Bern
Bern, 3010
Hopitaux Universitaires de Geneve
Geneva, 1205
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Luzerner Kantonsspital
Lucerne, 6000
Kantonsspital St Gallen
Sankt Gallen, 9007
Universitaetsspital Zuerich
Zurich, 8091
United Kingdom7 sites
Northwick Park Hospital
Harrow, HA1 3UJ
St James University Hospital, St James Institute of Oncology
Leeds, LS9 7TF
Royal Liverpool University Hospital
Liverpool, L7 8YA
St Bartholomews Hospital
London, EC1A 7BE
St Georges Hospital
London, SW17 0QT
Manchester Royal Infirmary
Manchester, M13 9WL
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Poland6 sites
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Krakow, 31-826
Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
Poznan, 60-569
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367
Germany5 sites
Universitätsklinikum Dresden
Dresden, 01307
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, 60590
Universitätsklinikum Halle/Saale
Halle, 06120
Städtisches Klinikum München GmbH
München, 80804
Klinikum Oldenburg AoR
Oldenburg, 26133
Greece4 sites
Evangelismos Hospital
Athens, 10676
Laiko General Hospital of Athens
Athens, 11527
Attikon University Hospital
Athens, 12462
University Hospital of Patras
Pátrai, 26504
Portugal4 sites
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023
Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos
Lisbon, 1169-050
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-035
Centro Hospitalar do Porto EPE - Hospital de Santo Antonio
Porto, 4099-001
Austria3 sites
Ordensklinikum Linz Elisabethinen
Linz, 4020
Landeskrankenhaus Salzburg
Salzburg, 5020
Hanuschkrankenhaus
Vienna, 1140
Czechia3 sites
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Plzen
Pilsen, 304 60
Ustav hematologie a krevni transfuze
Prague, 128 20
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Erasmus Medical Center
Rotterdam, 3015 CE
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
About this study
Official title: An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.
Read the 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.
- Keywords
- Blincyto
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients initiating Blinatumomab | Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with specified AEs as mentioned in description
- Neurological adverse events
- Opportunistic infections
- Cytokine release syndrome
Measured: Estimated to be 100 days
Time to onset of first specified AEs
Time to onset of first specified AEs.
Measured: 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
Measured: 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.
Measured: Estimated to be 100 days
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Estimated to be 100 days
Blincyto utilisation: Number of completed cycles
Measured: Estimated to be 100 days
Blincyto utilisation: Total number of days of administration
Measured: Estimated to be 100 days
Blincyto utilisation: Proportion of patients with dose step-up on Day 8
Measured: Day 8
Blincyto utilisation: Number of cycles initiated
Measured: Estimated to be 100 days
Blincyto utilisation: Number of bag changes
Measured: Estimated to be 100 days
Blincyto utilisation: Proportion of patients with treatment changes
Treatment changes include interruption, discontinuation, and dose reduction.
Measured: 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.
Measured: Estimated to be 100 days
Select healthcare resource use: Total number of days of inpatient Blincyto treatment
Measured: Estimated to be 100 days
Select healthcare resource use: Proportion of treatment days that were inpatient
Measured: Estimated to be 100 days
Select healthcare resource use: Incidence of hospitalization not related to infusion
Measured: Estimated to be 100 days
Select healthcare resource use: Length of hospital stay not related to infusion
Measured: Estimated to be 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start22 Mar 2017
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blincyto Use in Routine Clinical PracticeStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117621
- Sponsor's protocol ID
- 20150136
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2017
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
- ClinicalTrials.gov ID
- NCT03117621
- Acronym / sponsor ID
- 20150136
- Keywords
- Blincyto
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients initiating Blinatumomab | – | –Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients receiving Blincyto at participating clinical centres after country-specific reimbursement of Blincyto in the Europe.
Key inclusion criteria (1 listed)
- Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with specified AEs as mentioned in description
Time frame: Estimated to be 100 days
* Neurological adverse events * Opportunistic infections * Cytokine release syndrome
Time to onset of first specified AEs
Time frame: Estimated to be 100 days
Time to onset of first specified AEs.
Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events)
Time frame: Estimated to be 100 days
Summary of duration of specified AEs (all events and resolved/recovered events) * Neurological adverse events * Opportunistic Infections
Proportion of Blincyto administrations with medication errors
Time frame: Estimated to be 100 days
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.
20 secondary outcomes
Proportion of patients with AEs as detailed in the description
Time frame: Estimated to be 100 days
Proportion of patients achieving Complete Remission overall and amongst patient sub-groups
Time frame: Estimated to be 100 days
Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups
Time frame: Estimated to be 100 days
Proportion of patients receiving allogeneic HSCT amongst patient sub-groups
Time frame: Estimated to be 100 days
1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups
Time frame: Estimated to be 100 days
Relapse-free survival (RFS) time amongst patient sub-groups
Time frame: Estimated to be 100 days
Disease Free Survival (DFS) time
Time frame: Estimated to be 100 days
Overall survival (OS) time amongst patient sub-groups
Time frame: Estimated to be 100 days
Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto
Time frame: Estimated to be 100 days
Blincyto utilisation: Number of completed cycles
Time frame: Estimated to be 100 days
Blincyto utilisation: Total number of days of administration
Time frame: Estimated to be 100 days
Blincyto utilisation: Proportion of patients with dose step-up on Day 8
Time frame: Day 8
Blincyto utilisation: Number of cycles initiated
Time frame: Estimated to be 100 days
Blincyto utilisation: Number of bag changes
Time frame: Estimated to be 100 days
Blincyto utilisation: Proportion of patients with treatment changes
Time frame: Estimated to be 100 days
Select healthcare resource use: Number of bag changes in each setting
Time frame: Estimated to be 100 days
Select healthcare resource use: Total number of days of inpatient Blincyto treatment
Time frame: Estimated to be 100 days
Select healthcare resource use: Proportion of treatment days that were inpatient
Time frame: Estimated to be 100 days
Select healthcare resource use: Incidence of hospitalization not related to infusion
Time frame: Estimated to be 100 days
Select healthcare resource use: Length of hospital stay not related to infusion
Time frame: Estimated to be 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
80 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blincyto Use in Routine Clinical Practice, run by Amgen at 80 sites in 13 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 1 inclusion and 4 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in Italy, France, Switzerland, United Kingdom, Poland and 8 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with specified AEs as mentioned in description (time frame: Estimated to be 100 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.