MyelofibrosisNCT07357441
A Study to Evaluate the Demographics and Treatment Patterns of Myelofibrosis Patients Treated With Ruxolitinib in Turkey
An observational study of Myelofibrosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a non-interventional retrospective study. Data from patients who were diagnosed with myelofibrosis (MF) (primary MF, post-polycythemia vera MF \& post-essential thrombocythemia MF) and treated with ruxolitinib for at least 3 months collectively were collected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myelofibrosis
- How many people
- 355 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 28 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, non-interventional cohort study.
Who may be able to join
- Diagnosed with MF
- Treated with ruxolitinib for at least 3 months
Who cannot join
- None identified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Chart Review Study to Evaluate the Demographics and Treatment Patterns of Myelofibrosis in Routine Practice After Ruxolitinib Approval in Turkey
This was a non-interventional retrospective study. Data from patients who were diagnosed with myelofibrosis (MF) (primary MF, post-polycythemia vera MF \& post-essential thrombocythemia MF) and treated with ruxolitinib for at least 3 months collectively were collected. The baseline visit was the visit that the patient started ruxolitinib treatment. Data was collected between January 01, 2015 and December 31, 2022. The main baseline clinical and laboratory data of the cohort with at least 3 months of ruxolitinib treatment was documented in order to identify real life patient data in Turkey.
All the data was transferred to a clinical report form (CRF), then to the Statistical Package for the Social Sciences (SPSS) software in an anonymous fashion. The source documents were secured for quality control of the data. The quality control of the data was controlled by an unbiased data entry coordinator.
- Conditions
- Myelofibrosis
- Keywords
- Real life, Retrospective, Chart review
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib Group 1 | Patients diagnosed with intermediate-1 risk MF according to the Dynamic International Prognostic Scoring System Plus (DIPSS+) at the initial visit who were treated with ruxolitinib. | |
| Ruxolitinib Group 2 | Patients diagnosed with intermediate-2 and High risk MF according to the DIPSS+ at the initial visit who were treated with ruxolitinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Measured: Baseline
Number of Patients by Gender
Measured: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included:
- Janus Kinase (JAK) mutation (yes/no)
- MF-relevant type of mutation
- MF Type
- Cytogenic risk assessment (favorable/unfavorable karyotype)
Measured: Baseline
Time From Diagnosis to Initiation of Ruxolitinib
Measured: Baseline
Number of Patients by DIPSS+ Risk Stratification
DIPSS+ is a prognostic scoring system used to assign MF patients into 1 of 4 risk categories based on the 8 risk factors: age, hemoglobin level, leukocyte count, percentage of circulating blast cells, presence of constitutional symptoms, platelet count, need for red blood cell transfusion, and unfavorable karyotype. The 4 risk categories are as follows:
- Low risk (0 points)
- Intermediate-1 risk (1 point)
- Intermediate-2 risk (2-3 points)
- High risk (4-6 points)
Measured: Baseline, Month 12
Percentage of Patients With Blood Transfusions
Measured: Baseline, Month 3, 6, and 12
Percentage of Patients With Splenomegaly
Measured: Baseline, Month 3, 6, and 12
Change From Baseline in Percentage of Patients With Splenomegaly
Measured: Baseline, Month 12
Percentage of Patients Categorized by Spleen Size
Spleen size was categorized as follows:
- 20 centimeters (cm) or smaller
- Bigger than 20 cm
Measured: Baseline, Month 3, 6, and 12
Hemoglobin Levels
Measured: Baseline, Month 3, 6, and 12
Hematocrit Levels
Measured: Baseline, Month 3, 6, and 12
White Blood Cell (Leukocyte) Count
Measured: Baseline, Month 3, 6, and 12
Platelet Count
Measured: Baseline, Month 3, 6, and 12
Lactate Dehydrogenase (LDH) Levels
Measured: Baseline, Month 3, 6, and 12
Secondary outcomes (3)
Number of Patients With Hematological and Non-hematological Adverse Events
Measured: Up to 12 months
Percentage of Patients With Anemia and Thrombocytopenia
Measured: Baseline, Month 3, 6, and 12
Percentage of Patients With Treatment Adjustments due to Anemia and Thrombocytopenia
Treatment adjustments included dose modification, treatment interruption, and treatment discontinuation.
Measured: Month 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start7 Apr 2022
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
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 Novartis PharmaceuticalsThe 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
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357441
- Sponsor's protocol ID
- CINC424ATR01
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review Study to Evaluate the Demographics and Treatment Patterns of Myelofibrosis in Routine Practice After Ruxolitinib Approval in Turkey
- ClinicalTrials.gov ID
- NCT07357441
- Acronym / sponsor ID
- CINC424ATR01
- Conditions
- Myelofibrosis
- Keywords
- Real life, Retrospective, Chart review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 22 Jan 2026 (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.
This was a non-interventional retrospective study. Data from patients who were diagnosed with myelofibrosis (MF) (primary MF, post-polycythemia vera MF \& post-essential thrombocythemia MF) and treated with ruxolitinib for at least 3 months collectively were collected. The baseline visit was the visit that the patient started ruxolitinib treatment. Data was collected between January 01, 2015 and December 31, 2022. The main baseline clinical and laboratory data of the cohort with at least 3 months of ruxolitinib treatment was documented in order to identify real life patient data in Turkey.
All the data was transferred to a clinical report form (CRF), then to the Statistical Package for the Social Sciences (SPSS) software in an anonymous fashion. The source documents were secured for quality control of the data. The quality control of the data was controlled by an unbiased data entry coordinator.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib Group 1 | – | –Patients diagnosed with intermediate-1 risk MF according to the Dynamic International Prognostic Scoring System Plus (DIPSS+) at the initial visit who were treated with ruxolitinib. |
| Ruxolitinib Group 2 | – | –Patients diagnosed with intermediate-2 and High risk MF according to the DIPSS+ at the initial visit who were treated with ruxolitinib. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (2 listed)
- Diagnosed with MF
- Treated with ruxolitinib for at least 3 months
Key exclusion criteria (1 listed)
- None identified.
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
Age
Time frame: Baseline
Number of Patients by Gender
Time frame: Baseline
Number of Patients by Clinical Characteristic Category
Time frame: Baseline
Clinical characteristics included: * Janus Kinase (JAK) mutation (yes/no) * MF-relevant type of mutation * MF Type * Cytogenic risk assessment (favorable/unfavorable karyotype)
Time From Diagnosis to Initiation of Ruxolitinib
Time frame: Baseline
Number of Patients by DIPSS+ Risk Stratification
Time frame: Baseline, Month 12
DIPSS+ is a prognostic scoring system used to assign MF patients into 1 of 4 risk categories based on the 8 risk factors: age, hemoglobin level, leukocyte count, percentage of circulating blast cells, presence of constitutional symptoms, platelet count, need for red blood cell transfusion, and unfavorable karyotype. The 4 risk categories are as follows: * Low risk (0 points) * Intermediate-1 risk (1 point) * Intermediate-2 risk (2-3 points) * High risk (4-6 points)
Percentage of Patients With Blood Transfusions
Time frame: Baseline, Month 3, 6, and 12
Percentage of Patients With Splenomegaly
Time frame: Baseline, Month 3, 6, and 12
Change From Baseline in Percentage of Patients With Splenomegaly
Time frame: Baseline, Month 12
Percentage of Patients Categorized by Spleen Size
Time frame: Baseline, Month 3, 6, and 12
Spleen size was categorized as follows: * 20 centimeters (cm) or smaller * Bigger than 20 cm
Hemoglobin Levels
Time frame: Baseline, Month 3, 6, and 12
Hematocrit Levels
Time frame: Baseline, Month 3, 6, and 12
White Blood Cell (Leukocyte) Count
Time frame: Baseline, Month 3, 6, and 12
Platelet Count
Time frame: Baseline, Month 3, 6, and 12
Lactate Dehydrogenase (LDH) Levels
Time frame: Baseline, Month 3, 6, and 12
3 secondary outcomes
Number of Patients With Hematological and Non-hematological Adverse Events
Time frame: Up to 12 months
Percentage of Patients With Anemia and Thrombocytopenia
Time frame: Baseline, Month 3, 6, and 12
Percentage of Patients With Treatment Adjustments due to Anemia and Thrombocytopenia
Time frame: Month 3, 6, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis, run by Novartis Pharmaceuticals at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: Baseline). The study lists 14 primary outcomes in all. 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 22 Jan 2026.