Blincyto Use in Routine Clinical Practice Clinical Trial
Official title:
An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
| NCT number | NCT03117621 |
| Other study ID # | 20150136 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 22, 2017 |
| Est. completion date | February 29, 2024 |
| Verified date | March 2024 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.
| Status | Completed |
| Enrollment | 279 |
| Est. completion date | February 29, 2024 |
| Est. primary completion date | February 29, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Ordensklinikum Linz Elisabethinen | Linz | |
| Austria | Landeskrankenhaus Salzburg | Salzburg | |
| Austria | Hanuschkrankenhaus | Wien | |
| Czechia | Fakultni nemocnice Hradec Kralove | Hradec Kralove | |
| Czechia | Fakultni nemocnice Plzen | Plzen | |
| Czechia | Ustav hematologie a krevni transfuze | Praha 2 | |
| Finland | Helsinki University Central Hospital | Helsinki | |
| France | Centre Hospitalier Universitaire Dieu Angers | Angers cedex 09 | |
| France | Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz | Besançon | |
| France | Hopital d Instruction des Armee | Clamart | |
| France | Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing | Clermont-Ferrand | |
| France | Hôpital Henri Mondor | Créteil | |
| France | Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez | Lille | |
| France | Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi | Montpellier Cedex 5 | |
| France | Centre Hospitalier Universitaire de Nice | Nice cedex 3 | |
| France | Hopital Saint Louis | Paris | |
| France | Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque | Pessac Cedex | |
| France | Centre Hospitalier Lyon Sud | Pierre-Benite | |
| France | Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie | Poitiers | |
| France | Institut de Cancerologie Strasbourg | Strasbourg | |
| France | Centre Hospitalier Universitaire de Toulouse - Hopital Purpan | Toulouse cedex 9 | |
| France | Centre Hospitalier Universitaire de Nancy - Hopital de Brabois | Vandoeuvre les Nancy Cedex | |
| Germany | Universitätsklinikum Dresden | Dresden | |
| Germany | Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main | Frankfurt am Main | |
| Germany | Universitätsklinikum Halle/Saale | Halle (Saale) | |
| Germany | Städtisches Klinikum München GmbH | München | |
| Germany | Klinikum Oldenburg AoR | Oldenburg | |
| Greece | Attikon University Hospital | Athens | |
| Greece | Evangelismos Hospital | Athens | |
| Greece | Laiko General Hospital of Athens | Athens | |
| Greece | University Hospital of Patras | Patra | |
| Italy | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | |
| Italy | Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi | Bologna | |
| Italy | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico | Catania | |
| Italy | Azienda Ospedaliero Universitaria Careggi | Firenze | |
| Italy | Ospedale Policlinico San Martino IRCCS | Genova | |
| Italy | Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milano | |
| Italy | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Azienda Ospedaliero Universitaria di Modena | Modena | |
| Italy | Azienda Ospedaliera Universitaria Federico II | Napoli | |
| Italy | Presidio Ospedaliero Andrea Tortora | Pagani (SA) | |
| Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | |
| Italy | Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia | Perugia | |
| Italy | Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito | Pescara | |
| Italy | Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova | Reggio Emilia | |
| Italy | Azienda Ospedaliera Policlinico Umberto I | Roma | |
| Italy | Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette | Torino | |
| Italy | Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I | Torino | |
| Italy | Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo | Venezia | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| Netherlands | Universitair Medisch Centrum Utrecht | Utrecht | |
| Poland | SPZOZ Szpital Uniwersytecki w Krakowie | Krakow | |
| Poland | Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo | Kraków | |
| Poland | Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu | Poznan | |
| Poland | Instytut Hematologii i Transfuzjologii | Warszawa | |
| Poland | Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warszawa | |
| Poland | Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | |
| Portugal | Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos | Lisboa | |
| Portugal | Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria | Lisboa | |
| Portugal | Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE | Lisboa | |
| Portugal | Centro Hospitalar do Porto EPE - Hospital de Santo Antonio | Porto | |
| Sweden | Akademiska Sjukhuset | Uppsala | |
| Switzerland | Kantonsspital Aarau | Aarau | |
| Switzerland | Universitaetsspital Basel | Basel | |
| Switzerland | Instituto Oncologico Della Svizzera Italiana | Bellinzona | |
| Switzerland | Inselspital Bern | Bern | |
| Switzerland | Hopitaux Universitaires de Geneve | Geneve | |
| Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
| Switzerland | Luzerner Kantonsspital | Luzern | |
| Switzerland | Kantonsspital St Gallen | St Gallen | |
| Switzerland | Universitaetsspital Zuerich | Zuerich | |
| United Kingdom | Northwick Park Hospital | Harrow | |
| United Kingdom | St James University Hospital, St James Institute of Oncology | Leeds | |
| United Kingdom | Royal Liverpool University Hospital | Liverpool | |
| United Kingdom | St Bartholomews Hospital | London | |
| United Kingdom | St Georges Hospital | London | |
| United Kingdom | Manchester Royal Infirmary | Manchester | |
| United Kingdom | Freeman Hospital | Newcastle Upon Tyne |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Austria, Czechia, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with specified AEs as mentioned in description | Neurological adverse events Opportunistic infections Cytokine release syndrome |
Estimated to be 100 days | |
| Primary | Time to onset of first specified AEs | Time to onset of first specified AEs. | Estimated to be 100 days | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Blincyto utilisation: Number of completed cycles | Estimated to be 100 days | ||
| Secondary | Blincyto utilisation: Total number of days of administration | Estimated to be 100 days | ||
| Secondary | Blincyto utilisation: Proportion of patients with dose step-up on Day 8 | Day 8 | ||
| Secondary | Blincyto utilisation: Number of cycles initiated | Estimated to be 100 days | ||
| Secondary | Blincyto utilisation: Number of bag changes | Estimated to be 100 days | ||
| Secondary | Blincyto utilisation: Proportion of patients with treatment changes | Treatment changes include interruption, discontinuation, and dose reduction. | Estimated to be 100 days | |
| Secondary | 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 | |
| Secondary | Select healthcare resource use: Total number of days of inpatient Blincyto treatment | Estimated to be 100 days | ||
| Secondary | Select healthcare resource use: Proportion of treatment days that were inpatient | Estimated to be 100 days | ||
| Secondary | Select healthcare resource use: Incidence of hospitalization not related to infusion | Estimated to be 100 days | ||
| Secondary | Select healthcare resource use: Length of hospital stay not related to infusion | Estimated to be 100 days |