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

Myelofibrosis Clinical Trial

— METER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444972
• Other study ID #: H23-122
• Status: Completed
• Start date: August 23, 2022
• Est. completion date: November 14, 2023

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 998
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Colombia,  Greece,  Italy,  Mexico,  Poland,  Portugal,  Romania,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from Diagnosis of Myelofibrosis (MF) to Initial Treatment	Time from diagnosis of MF to initial treatment.	Up to Week 156
Primary	Duration of Initial Treatment	Duration of initial treatment.	Up to Week 156
Primary	Duration of Second Treatment	Duration of second treatment.	Up to Week 156
Primary	Duration of Subsequent Treatments	Duration of subsequent treatments.	Up to Week 156