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Observational Study of Blinatumomab

Sponsor
Amgen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03117621
Collaborator
(none)
279
Enrollment
81
Locations
84
Anticipated Duration (Months)
3.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    279 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
    Actual Study Start Date :
    Mar 22, 2017
    Anticipated Primary Completion Date :
    Mar 21, 2024
    Anticipated Study Completion Date :
    Mar 21, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients initiating Blinatumomab

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with specified AEs as mentioned in description [Estimated to be 100 days]

      Neurological adverse events Opportunistic infections

    2. Time to onset of first specified AEs [Estimated to be 100 days]

      Time to onset of first specified AEs.

    3. Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events) [Estimated to be 100 days]

      Summary of duration of specified AEs (all events and resolved/recovered events) Specified AEs Neurological adverse events Opportunistic Infections Infusion reactions, including cytokine release syndrome Tumour lysis syndrome Capillary leak syndrome Elevated liver enzymes Febrile neutropenia and neutropenia Decreased immunoglobulin Leukoencephalopathy (including PML) Thromboembolic events (including DIC) Immunogenicity (suspected with antibody test outcome) Worsening of hepatic impairment in patients with hepatic impairment.

    4. Proportion of Blincyto administrations with medication errors [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.

    Secondary Outcome Measures

    1. Proportion of patients with AEs as detailed in the description [Estimated to be 100 days]

      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.

    2. Proportion of patients achieving Complete Remission overall and amongst patient sub-groups [Estimated to be 100 days]

      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.

    3. Proportion of patients achieving CR/CRh*/CRi overall and amongst patient sub-groups [Estimated to be 100 days]

      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.

    4. Proportion of patients receiving allogeneic HSCT overall and amongst patient sub-groups [Estimated to be 100 days]

      Proportion of patients receiving allogeneic HSCT overall and amongst patient sub-groups. Defined for the subset of subjects who achieved CR.

    5. 1-year and 100-day mortality proportion after allogeneic HSCT overall and amongst patient sub-groups [Estimated to be 100 days]

      1-year and 100-day mortality proportion after allogeneic HSCT overall and amongst patient sub-groups. Defined for the subset of subjects who achieved CR.

    6. Relapse-free survival (RFS) time overall and amongst patient sub-groups [Estimated to be 100 days]

      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.

    7. Disease Free Survival (DFS) time [Estimated to be 100 days]

      Disease Free Survival time - Defined as time from initiation of Blincyto (for MRD positive patients at initiation) until date of relapse or death.

    8. Overall survival (OS) time overall and amongst patient sub-groups [Estimated to be 100 days]

      Overall survival (OS) time - defined as time from initiation of Blincyto until death.

    9. Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto [Estimated to be 100 days]

      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.

    10. Blincyto utilisation: Number of completed cycles [Estimated to be 100 days]

    11. Blincyto utilisation: Total number of days of administration [Estimated to be 100 days]

    12. Blincyto utilisation: Proportion of patients with dose step-up on Day 8 [Day 8]

    13. Blincyto utilisation: Number of cycles initiated [Estimated to be 100 days]

    14. Blincyto utilisation: Number of bag changes [Estimated to be 100 days]

    15. Blincyto utilisation: Proportion of patients with treatment changes [Estimated to be 100 days]

      Treatment changes include interruption, discontinuation, and dose reduction.

    16. Select healthcare resource use: Number of bag changes in each setting [Estimated to be 100 days]

      Setting of blincyto bag changes include in the hospital, in the outpatient clinic, or at home.

    17. Select healthcare resource use: Total number of days of inpatient Blincyto treatment [Estimated to be 100 days]

    18. Select healthcare resource use: Proportion of treatment days that were inpatient [Estimated to be 100 days]

    19. Select healthcare resource use: Incidence of hospitalization not related to infusion [Estimated to be 100 days]

    20. Select healthcare resource use: Length of hospital stay not related to infusion [Estimated to be 100 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ordensklinikum Linz Elisabethinen Linz Austria 4020
    2 Landeskrankenhaus Salzburg Salzburg Austria 5020
    3 Hanuschkrankenhaus Wien Austria 1140
    4 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    5 Fakultni nemocnice Plzen Plzen Czechia 304 60
    6 Ustav hematologie a krevni transfuze Praha 2 Czechia 128 20
    7 Helsinki University Central Hospital Helsinki Finland 00029
    8 Centre Hospitalier Universitaire Dieu Angers Angers cedex 09 France 49933
    9 Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz Besançon France 25030
    10 Hopital d Instruction des Armee Clamart France 92140
    11 Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing Clermont-Ferrand France 63000
    12 Hôpital Henri Mondor Créteil France 94010
    13 Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Lille France 59037
    14 Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi Montpellier Cedex 5 France 34295
    15 Centre Hospitalier Universitaire de Nice Nice cedex 3 France 06202
    16 Hopital Saint Louis Paris France 75010
    17 Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque Pessac Cedex France 33604
    18 Centre Hospitalier Lyon Sud Pierre-Benite France 69495
    19 Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie Poitiers France 86000
    20 Institut de Cancerologie Strasbourg Strasbourg France 67033
    21 Centre Hospitalier Universitaire de Toulouse - Hopital Purpan Toulouse cedex 9 France 31059
    22 Centre Hospitalier Universitaire de Nancy - Hopital de Brabois Vandoeuvre les Nancy Cedex France 54511
    23 Universitätsklinikum Dresden Dresden Germany 01307
    24 Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main Frankfurt am Main Germany 60590
    25 Universitätsklinikum Halle/Saale Halle (Saale) Germany 06120
    26 Städtisches Klinikum München GmbH München Germany 80804
    27 Klinikum Oldenburg AoR Oldenburg Germany 26133
    28 Evangelismos Hospital Athens Greece 10676
    29 Laiko General Hospital of Athens Athens Greece 11527
    30 Attikon University Hospital Athens Greece 12462
    31 University Hospital of Patras Patra Greece 26504
    32 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Italy 24127
    33 Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi Bologna Italy 40138
    34 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Brescia Italy 25123
    35 Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico Catania Italy 95123
    36 Azienda Ospedaliero Universitaria Careggi Firenze Italy 50134
    37 Ospedale Policlinico San Martino IRCCS Genova Italy 16132
    38 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano Italy 20122
    39 Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    40 Azienda Ospedaliero Universitaria di Modena Modena Italy 41100
    41 Azienda Ospedaliera Universitaria Federico II Napoli Italy 80131
    42 Presidio Ospedaliero Andrea Tortora Pagani (SA) Italy 84016
    43 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100
    44 Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia Perugia Italy 06156
    45 Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito Pescara Italy 65100
    46 Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova Reggio Emilia Italy 42123
    47 Azienda Ospedaliera Policlinico Umberto I Roma Italy 00161
    48 Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette Torino Italy 10126
    49 Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I Torino Italy 10128
    50 Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo Venezia Italy 30174
    51 Academisch Medisch Centrum Amsterdam Netherlands 1105 AZ
    52 Erasmus Medical Center Rotterdam Netherlands 3015 CE
    53 Universitair Medisch Centrum Utrecht Utrecht Netherlands 3584 CX
    54 SPZOZ Szpital Uniwersytecki w Krakowie Krakow Poland 31-501
    55 Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo Kraków Poland 31-826
    56 Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu Poznan Poland 60-569
    57 Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warszawa Poland 02-097
    58 Instytut Hematologii i Transfuzjologii Warszawa Poland 02-776
    59 Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw Poland 50-367
    60 Centro Hospitalar Universitario de Coimbra Coimbra Portugal 3000-075
    61 Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE Lisboa Portugal 1099-023
    62 Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos Lisboa Portugal 1169-050
    63 Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria Lisboa Portugal 1649-035
    64 Centro Hospitalar do Porto EPE - Hospital de Santo Antonio Porto Portugal 4099-001
    65 Akademiska Sjukhuset Uppsala Sweden 751 85
    66 Kantonsspital Aarau Aarau Switzerland 5001
    67 Universitaetsspital Basel Basel Switzerland 4031
    68 Instituto Oncologico Della Svizzera Italiana Bellinzona Switzerland 6501
    69 Inselspital Bern Bern Switzerland 3010
    70 Hopitaux Universitaires de Geneve Geneve Switzerland 1205
    71 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland 1011
    72 Luzerner Kantonsspital Luzern Switzerland 6000
    73 Kantonsspital St Gallen St Gallen Switzerland 9007
    74 Universitaetsspital Zuerich Zuerich Switzerland 8091
    75 Northwick Park Hospital Harrow United Kingdom HA1 3UJ
    76 St James University Hospital, St James Institute of Oncology Leeds United Kingdom LS9 7TF
    77 Royal Liverpool University Hospital Liverpool United Kingdom L7 8YA
    78 St Bartholomews Hospital London United Kingdom EC1A 7BE
    79 St Georges Hospital London United Kingdom SW17 0QT
    80 Manchester Royal Infirmary Manchester United Kingdom M13 9WL
    81 Freeman Hospital Newcastle Upon Tyne United Kingdom NE7 7DN

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT03117621
    Other Study ID Numbers:
    • 20150136
    First Posted:
    Apr 18, 2017
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Blincyto

    Study Results

    No Results Posted as of Mar 25, 2022