MyelofibrosisNCT06516406
Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
An observational study of Myelofibrosis and Primary Myelofibrosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 26 sites in Italy.
Trial summary
The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Primary Myelofibrosis, Secondary Myelofibrosis
- How many people
- 1,055 participants
- Where
- 26 sitesItaly
- Study dates
- 6 May 2022to 31 May 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is observational multicenter retrospective and prospective cohort will be offered consecutively to any patient with primary or secondary myelofibrosis who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The study will be conducted in the study-participating OUs of Hematology, and an estimated total of 1015 patients who initiated therapy with Ruxolitinib between 2008 and the end of the study are expected to participate in this study.
Who may be able to join
- Age ≥ 18 years
- Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice.
- Availability of data on clinical history prior to initiation of Ruxolitinib therapy
- Obtaining informed consent for data collection and processing
Who cannot join
- None
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
Italy26 sites, 26 recruiting
- Recruiting
IRCCS Policlinico Sant'Orsola
Bologna, Emilia-Romagna, 40138
Francesca Palandri, MD, PhD, +390512143044, francesca.palandri@unibo.it
- Recruiting
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
Cagliari, Sardinia, 09131
Giovanni Caocci, MD, +39 070 52965520, giovanni.caocci@unica.it
- Recruiting
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
Catania, Sicily, 95124
Giuseppe Palumbo, MD, +39 3283423820, palumbo.giuseppealberto@gmail.com
- Recruiting
Azienda Ospedaliera Annunziata
Cosenza, Calabria, 87100
Francesco Mendicino, MD, +39 3383138761, dott.mendicino.ematologiacs@gmail.com
- Recruiting
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
Ferrara, Emilia-Romagna, 44124
Francesco Cavazzini, MD, +39 0532236987, cvzfnc@unife.it
- Recruiting
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
Genoa, Liguria, 16132
Roberto Lemoli, MD, +39 0103538978, roberto.lemoli@unige.it
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Alessandra Iurlo, MD, +39 02550333623463, alessandra.iurlo@policlinico.mi.it
- Recruiting
Ospedale San Gerardo
Monza, Lombardy, 20900
Elena Elli, MD, +39 039 2339859, elena.elli@libero.it
- Recruiting
Università degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo
Naples, Campania, 80131
Novella Pugliese, MD, +39 0817462037, novella.pugliese@unina.it
- Recruiting
AOU di Padova
Padova, Veneto, 35128
Gianni Binotto, MD, +39 0498217091, gianni.binotto@unipd.it
- Recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, 43126
Monica Crugnola, MD, +39 0521704749, mcrugnola@ao.pr.it
- Recruiting
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
Pesaro, The Marches, 61122
Alessandro Isidori, MD, +39 0721364022, alessandro.isidori@ospedalimarchenord.it
- Recruiting
AUSL di Piacenza - Palazzine Medicine Specialistiche
Piacenza, Emilia-Romagna, 29121
Costanza Bosi, MD, +39 0523303728, c.bosi@ausl.pc.it
- Recruiting
Dipartimento Oncoematologico - AUSL della Romagna
Ravenna, Emilia-Romagna, 48121
Francesco Lanza, MD, +39 0544285752, francesco.lanza@auslromagna.it
- Recruiting
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, Calabria, 89124
Bruno Martino, MD, +39 0965397195, brunmartin@libero.it
- Recruiting
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, 47923
Simona Tomassetti, MD, +39 0541705862, simona.tomassetti@auslromagna.it
- Recruiting
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
Rome, Lazio, 00161
Massimo Breccia, MD, +39 0685795440, breccia@bce.uniroma1.it
- Recruiting
Ospedale S. Eugenio
Rome, Lazio
Elisabetta Abruzzese, MD, elisabetta.abruzzese@uniroma2.it
- Recruiting
Policlinico S.Maria alle Scotte
Siena, Tuscany, 53100
Monica Bocchia, MD, +39 0577586740, monica.bocchia@unisi.it
- Recruiting
Ospedale San Luigi Gonzaga - Regione Gonzole
Turin, Piedmont, 10043
Daniela Cilloni, MD, +39 01190261, daniela.cilloni@unito.it
- Recruiting
Department of Oncology, University of Torino
Turin, Piedmont, 10124
Eloise Beggiato, MD, +39 011 6705492, ebeggiato@cittadellasalute.to.it
- Recruiting
Città della Salute e della Scienza
Turin, Piedmont, 10126
Giulia Benevolo, MD, +39 0116336177, gbenevolo@cittadellasalute.to.it
- Recruiting
A. O. Ordine Mauriziano di Torino
Turin, Piedmont, 10128
Daniela Cilloni, MD, +39 011 508 1111, daniela.cilloni@unito.it
- Recruiting
A.O.U. Integrata di Udine
Udine, Friuli Venezia Giulia, 33100
Mario Tiribelli, MD, +39 0432 559666, mario.tiribelli@uniud.it
- Recruiting
A.O.U. Integrata Verona
Verona, Veneto, 37134
Massimiliano Bonifacio, MD, + 39 0458124443, massimiliano.bonifacio@univr.it
- Recruiting
Ospedale Belcolle
Viterbo, Lazio, 01100
Roberto Latagliata, MD, +39 3498687663, rob.lati@libero.it
About this study
The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The primary purpose is to determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, understood as long-term survival.
Read the detailed description
The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histological, cytogenetic, molecular, and radiological investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular. data on systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. The minimum planned duration of individual patient observation is 3 months and the planned duration of the study is 10 years.
- Keywords
- Safety, Efficacy
- Medical subject headings
- Primary Myelofibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Term Survival
To determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, in terms of long-term survival.
Measured: 10 years
Secondary outcomes (5)
Significance of peripheral blasts
To assess correlations between amount of peripheral blasts and response to treatment, leukaemic transformation, drug withdrawal and survival.
Measured: 10 years
Prognostic value of High Molecular Risk (HMR) mutations.
To assess the prognostic value of HMRs (via NGS) in MF patients treated with ruxolitinib and to develop a prognostic model that can be applied to patients before and during ruxolitinib therapy.
Measured: 10 years
To validate the use of the MTSS score
To validate the use of the MTSS score to assess post-ASCT survival of patients with MF
Measured: 10 years
Incidence of adverse events
To assess the incidence of adverse events in patients with myelofibrosis treated with ruxolitinib: thrombosis, haemorrhage, second neoplasms, blastic evolution.
Measured: 10 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To assess the toxicity of ruxolitinib therapy in the total cohort
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start6 May 2022
- Primary completion31 May 2032 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,055 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516406
- Sponsor's protocol ID
- RUX-MF
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
- ClinicalTrials.gov ID
- NCT06516406
- Acronym / sponsor ID
- RUX-MF
- Keywords
- Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,055 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 31 May 2032 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The primary purpose is to determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, understood as long-term survival.
Detailed description
The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histological, cytogenetic, molecular, and radiological investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular. data on systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. The minimum planned duration of individual patient observation is 3 months and the planned duration of the study is 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is observational multicenter retrospective and prospective cohort will be offered consecutively to any patient with primary or secondary myelofibrosis who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The study will be conducted in the study-participating OUs of Hematology, and an estimated total of 1015 patients who initiated therapy with Ruxolitinib between 2008 and the end of the study are expected to participate in this study.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice.
- Availability of data on clinical history prior to initiation of Ruxolitinib therapy
- Obtaining informed consent for data collection and processing
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long Term Survival
Time frame: 10 years
To determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, in terms of long-term survival.
5 secondary outcomes
Significance of peripheral blasts
Time frame: 10 years
Prognostic value of High Molecular Risk (HMR) mutations.
Time frame: 10 years
To validate the use of the MTSS score
Time frame: 10 years
Incidence of adverse events
Time frame: 10 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Related trials for Myelofibrosis
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RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis and Primary Myelofibrosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 26 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Palandri, MD, PhD (+390512143044, francesca.palandri@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long Term Survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.