CompletedPhase 2

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Austria, Belgium, Bulgaria51 participantsStarted 2017-03-31

Plain-language summary

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

Who can participate

Age range

18 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 or female patients aged ≥ 18 years of age.
. Patients must have been diagnosed with PMF, according to the 2016 revised International Standard Criteria, PPV MF or PET-MF, irrespective of JAK2 mutation status.
. Patients must have had palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
. Patients must have had hemoglobin less than 10 g/dL
. Patients must have had a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
. Patients must have had ECOG performance status of 0, 1, or 2.
. Patients must have had a peripheral blood blast percentage count of \< 10%.

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

Percentage of Participants With at Least 50% Reduction in Spleen Length From Baseline at Week 24

Timeframe: Baseline up to week 24

Trial details

NCT IDNCT02966353

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-24

Results submitted2020-02-13

View on ClinicalTrials.gov More Primary Myelofibrosis trials

Plain-language summary

Who can participate

Age range

18 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 or female patients aged ≥ 18 years of age.
. Patients must have been diagnosed with PMF, according to the 2016 revised International Standard Criteria, PPV MF or PET-MF, irrespective of JAK2 mutation status.
. Patients must have had palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
. Patients must have had hemoglobin less than 10 g/dL
. Patients must have had a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
. Patients must have had ECOG performance status of 0, 1, or 2.
. Patients must have had a peripheral blood blast percentage count of \< 10%.

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria