Clinical trial NCT05444972: A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelofibrosis
Keywords: Myelofibrosis
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 998
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants patients diagnosed with myelofibrosis and treated on or after the first date when ruxolitinib was approved in their country of residence and no later than 31 December 2021.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time from Diagnosis of Myelofibrosis (MF) to Initial Treatment
timeFrame: Up to Week 156
measure: Duration of Initial Treatment
timeFrame: Up to Week 156
measure: Duration of Second Treatment
timeFrame: Up to Week 156
measure: Duration of Subsequent Treatments
timeFrame: Up to Week 156
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center /ID# 252767
state: Alabama
city: West Hills
country: United States
facility: Wellness Oncology & Hematology /ID# 255591
state: California
city: Boston
country: United States
facility: Brigham & Women's Hospital /ID# 254312
state: Massachusetts
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 252768
state: Ohio
city: La Plata
country: Argentina
facility: Instituto FIDES /ID# 245526
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires /ID# 244373
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundaleu /Id# 244371
state: Ciuadad Autonoma De Buenos Aires
city: Douglas
country: Australia
facility: Townsville University Hospital /ID# 246585
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 246583
state: South Australia
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 246584
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 246586
state: Western Australia
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 247394
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 247392
city: Vancouver
country: Canada
facility: St. Paul's Hospital /ID# 249719
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health /ID# 248393
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 251334
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 249748
state: Ontario
city: Levis
country: Canada
facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 250449
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 250563
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 250674
state: Quebec
city: Baranquilla
country: Colombia
facility: Organizacion Clinica Bonnadona -PREVENIR S.A.S. /ID# 244589
state: Atlantico
city: Bogota DC
country: Colombia
facility: Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 246108
state: Cundinamarca
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota /ID# 244588
state: Cundinamarca
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S /ID# 248465
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe /ID# 244525
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 246159
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 246167
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 246163
state: Kriti
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis /ID# 246161
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 246165
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 246160
city: Piraeus
country: Greece
facility: METAXA Cancer Hospital of Piraeus /ID# 246164
city: RION Patras Achaia
country: Greece
facility: University General Hospital of Patras /ID# 246162
city: Cona
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 245149
state: Ferrara
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 245335
state: Lazio
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia /ID# 245415
state: Umbria
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 245716
city: Brescia
country: Italy
facility: ASST Spedali civili di Brescia /ID# 244910
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244909
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 245566
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 245075
city: Varese
country: Italy
facility: ASST Sette Laghi /ID# 245443
city: Viterbo
country: Italy
facility: Ospedale Belcolle /ID# 245726
city: Ciudad de México
country: Mexico
facility: Hospital de Especialidades CMN SigloXXI /ID# 244748
state: Ciudad De Mexico
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 244750
state: Nuevo Leon
city: Ciudad de Mexico
country: Mexico
facility: Hospital General de Mexico /ID# 244749
city: Warsaw
country: Poland
facility: Krzysztof Mądry Praktyka Lekarska /ID# 250485
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Specjalistyczna Praktyka Lekarska Witold Prejzner /ID# 250516
state: Pomorskie
city: Orzesze
country: Poland
facility: Specjalistyczna Praktyka Lekarska Grzegorz Helbig /ID# 250515
city: Łódź
country: Poland
facility: Joanna Góra-Tybor Specjalistyczna Praktyka Lekarska /ID# 250495
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra, EPE /ID# 244687
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 248203
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 244400
city: Brașov
country: Romania
facility: MedLife - Policlinica de Diagnostic Rapid /ID# 244395
state: Brasov
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni /ID# 245939
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina /ID# 245620
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 244393
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 250092
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 250093
city: Ankara
country: Turkey
facility: Gulhane Askeri Tip Academy /ID# 244134
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty /ID# 244131
city: Diyarbakir
country: Turkey
facility: Dicle Universitesi Tip /ID# 244137
city: Edirne, Istanbul
country: Turkey
facility: Trakya University Medical Facu /ID# 244132
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 244133
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 244130
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty /ID# 244135
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: