Myelofibrosis Clinical Trial
— METEROfficial title:
A Multi-Country, Real-World Study to Explore Treatment Patterns, Effectiveness and Healthcare Resource Utilization for Patients Diagnosed With Myelofibrosis Through Chart Review
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 |
Verified date | December 2023 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Argentina, Australia, Brazil, Canada, Colombia, Greece, Italy, Mexico, Poland, Portugal, Romania, Taiwan, Turkey,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
Not yet recruiting |
NCT06345495 -
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
|
Phase 2 | |
Terminated |
NCT04866056 -
Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
|
Phase 1/Phase 2 | |
Completed |
NCT02784496 -
Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis
|
Phase 2 | |
Completed |
NCT00069680 -
Genetic Analysis of Gray Platelet Syndrome
|
||
Active, not recruiting |
NCT04097821 -
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03289910 -
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
|
Phase 2 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Not yet recruiting |
NCT06397313 -
RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
|
Phase 2 | |
Not yet recruiting |
NCT06024915 -
A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
|
Phase 1 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Completed |
NCT02910258 -
Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis
|
||
Completed |
NCT00997386 -
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
|
Phase 2 | |
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Completed |
NCT00666549 -
Research Tissue Bank
|
||
Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
Terminated |
NCT00393380 -
Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
|
Phase 2 | |
Completed |
NCT00606437 -
Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants
|
Phase 1 | |
Active, not recruiting |
NCT03952039 -
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
|
Phase 3 | |
Not yet recruiting |
NCT04709458 -
Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis
|
Phase 1 |