CompletedNot Applicable

A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis

Germany1,012 participantsStarted 2012-09-20

Plain-language summary

This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female patients with Primary Myelofibrosis (PMF), post-Polycythemia Vera-Myelofibrosis (PPV-MF), or post-Essential Thrombocythemia-Myelofibrosis (post-ET-MF), for whom Jakavi® therapy is indicated. * Patients that were informed about all aspects of this NIS and provided written informed consent. Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability

Timeframe: Up to 36 months

Spleen size (or volume) reduction

Timeframe: Up to 36 months

Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: Up to 36 months

Change in the number of patients with constitutional symptoms

Timeframe: Up to 36 months

Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)

Timeframe: Baseline, month 1, month 3, month 6, month 12, month 24 and month 36

Assessment of the Quality of Life (QoL) - Short Form-36 (SF-36)

Timeframe: Baseline month 6, month 12, month 24 and month 36

Overall survival

Timeframe: Up to 36 months

Trial details

NCT IDNCT05044026

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-19

View on ClinicalTrials.gov More Primary Myelofibrosis trials

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety and tolerability

Timeframe: Up to 36 months

Spleen size (or volume) reduction

Timeframe: Up to 36 months

Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: Up to 36 months

Change in the number of patients with constitutional symptoms

Timeframe: Up to 36 months

Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)

Timeframe: Baseline, month 1, month 3, month 6, month 12, month 24 and month 36

Assessment of the Quality of Life (QoL) - Short Form-36 (SF-36)

Timeframe: Baseline month 6, month 12, month 24 and month 36

Overall survival

Timeframe: Up to 36 months