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A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05444972
Collaborator
(none)
1,000
Enrollment
50
Locations
5.6
Anticipated Duration (Months)
20
Patients Per Site
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs) in which bone marrow cells that produce blood cells develop and function abnormally. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with Myelofibrosis.

Data from approximately 1000 participants will be collected. No participants will be enrolled in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 156 weeks.

There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 156 weeks.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Multi-Country, Real-World Study to Explore Treatment Patterns, Effectiveness and Healthcare Resource Utilization for Patients Diagnosed With Myelofibrosis Through Chart Review
    Actual Study Start Date :
    Jul 15, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Participants Undergoing Chart Review

    Participants treated for myelofibrosis undergoing chart review.

    Outcome Measures

    Primary Outcome Measures

    1. Time from Diagnosis of Myelofibrosis (MF) to Initial Treatment [Up to Week 156]

      Time from diagnosis of MF to initial treatment.

    2. Duration of Initial Treatment [Up to Week 156]

      Duration of initial treatment.

    3. Duration of Second Treatment [Up to Week 156]

      Duration of second treatment.

    4. Duration of Subsequent Treatments [Up to Week 156]

      Duration of subsequent treatments.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Treated for myelofibrosis (MF) [primary myelofibrosis (PMF) and secondary myelofibrosis (SMF)].

    • Must have initiated their first treatment on or after the first date when ruxolitinib was approved in their country of residence and no later than 31 December 2021.

    Exclusion Criteria:
    • Having received MF treatment in a clinical trial setting.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto FIDES /ID# 245526 La Plata Buenos Aires Argentina 1900
    2 Hospital Italiano de Buenos Aires /ID# 244373 Ciudad Autonoma Buenos Aires Ciuadad Autonoma De Buenos Aires Argentina 1199
    3 Townsville University Hospital /ID# 246585 Douglas Queensland Australia 4814
    4 Royal Adelaide Hospital /ID# 246583 Adelaide South Australia Australia 5000
    5 Fiona Stanley Hospital /ID# 246584 Murdoch Western Australia Australia 6150
    6 Royal Perth Hospital /ID# 246586 Perth Western Australia Australia 6000
    7 Organizacion Clinica Bonnadona Prevenir /ID# 244589 Baranquilla Atlantico Colombia 080016
    8 Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 246108 Bogota DC Cundinamarca Colombia 111221
    9 Fundacion Santa Fe de Bogota /ID# 244588 Bogota Cundinamarca Colombia 11011
    10 Instituto Nacional de Cancerologia /ID# 244583 Bogotá Cundinamarca Colombia 111511
    11 Fundacion Oftalmologica de Santander - FOSCAL /ID# 244587 Floridablanca Santander Colombia 681004
    12 Hospital Pablo Tobon Uribe /ID# 244525 Medellin Colombia 50034
    13 General Hospital of Athens Laiko /ID# 246159 Athens Attiki Greece 11527
    14 University General Hospital Attikon /ID# 246167 Athens Attiki Greece 12462
    15 University General Hospital of Heraklion PA.G.N.I /ID# 246163 Heraklion Kriti Greece 71500
    16 General University Hospital of Alexandroupolis /ID# 246161 Alexandroupolis Greece 68100
    17 General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 246165 Athens Greece 10676
    18 University General Hospital of Ioannina /ID# 246160 Ioannina Greece 45500
    19 METAXA Cancer Hospital of Piraeus /ID# 246164 Piraeus Greece 18737
    20 University General Hospital of Patras /ID# 246162 RION Patras Achaia Greece 26504
    21 Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 245149 Cona Ferrara Italy 44124
    22 Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 245718 Rome Lazio Italy 00161
    23 Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 245335 Rome Lazio Italy 00168
    24 Azienda Ospedaliera di Perugia /ID# 245415 Perugia Umbria Italy 06129
    25 IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 245716 Bologna Italy 40138
    26 ASST Spedali civili di Brescia /ID# 244910 Brescia Italy 25123
    27 Azienda Ospedaliero Universitaria Careggi /ID# 246636 Florence Italy 50134
    28 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244909 Milan Italy 20122
    29 Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 245566 Novara Italy 28100
    30 Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 245075 Palermo Italy 90127
    31 Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 245414 Salerno Italy 84131
    32 ASST Sette Laghi /ID# 245443 Varese Italy 21100
    33 Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 245720 Verona Italy 37134
    34 Ospedale Belcolle /ID# 245726 Viterbo Italy 01100
    35 Centro Hospitalar e Universitario de Coimbra, EPE /ID# 244687 Coimbra Portugal 3000-075
    36 Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 248203 Lisboa Portugal 1649-035
    37 Centro Hospitalar Universitario de Sao Joao, EPE /ID# 244400 Porto Portugal 4200-319
    38 MedLife - Policlinica de Diagnostic Rapid /ID# 244395 Brașov Brasov Romania 500152
    39 Institutul Clinic Fundeni /ID# 245939 Bucharest Romania 925200
    40 Spitalul Clinic Colentina /ID# 245620 Bucuresti Romania 020121
    41 Institutul Oncologic Prof Dr I Chiricuta /ID# 244393 Cluj Napoca Romania 400015
    42 Krai Clinical Hospital /ID# 248090 Barnaul Russian Federation 656024
    43 Municipal Institution Central City Hospital No. 7 /ID# 248324 Ekaterinburg Russian Federation 620137
    44 Irkutsk Regional Clinical Hospital /ID# 248323 Irkutsk Russian Federation 664003
    45 Krai Clinical Hospital #1 /ID# 248321 Khabarovsk Russian Federation 680009
    46 Kirovsky Research Institute Hematology and Blood Transfusion /ID# 248503 Kirov Russian Federation 610027
    47 State Budgetary Health Institution of the Novosibirsk Region "City Clinical Hosp /ID# 248325 Novoisibirsk Russian Federation 630051
    48 Children's scientific clinical Center of infectious diseases of FMBA /ID# 248270 Saint Petersburg Russian Federation 197022
    49 Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 248089 Saint Petersburg Russian Federation 197341
    50 Sakhalin Regional Clinical Hospital /ID# 248088 Yuzhno-Sakhalinsk Russian Federation 693004

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05444972
    Other Study ID Numbers:
    • H23-122
    First Posted:
    Jul 6, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Myelofibrosis
    Cancer
    Additional relevant MeSH terms:
    Primary Myelofibrosis

    Study Results

    No Results Posted as of Jul 20, 2022