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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05444972
Other study ID # H23-122
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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