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Canakinumab for Myelofibrosis
Study Summary
This trial is testing Canakinumab as a treatment for primary myelofibrosis, post essential thrombocythemia/polycythemia vera related MF. Eligible patients will receive Canakinumab administered as a subcutaneous injection every 3 weeks for a core study period of 8 cycles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 203 Patients • NCT02059291Trial Design
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- I have had cancer before, but it was either cured locally or has been inactive for over a year.I have had a bone marrow or organ transplant before.I have been diagnosed with primary myelofibrosis or its advanced stages after ET/PV.I have a known heart condition.I am 18 years old or older.My spleen is enlarged, extending more than 5 cm below my rib cage.I have low hemoglobin, need regular blood transfusions, have an enlarged spleen, or a high MF-SAF score.I will get tested for COVID-19 if I have a fever or respiratory symptoms.I haven't taken steroids for my condition in the last 14 days.I agree to sign the consent form and follow the study's schedule and rules.I am willing to receive blood or platelet transfusions if needed.I have a history of HIV or active hepatitis B or C.I am 18 years old or older.I do not have an active, uncontrolled infection.I am not pregnant or breastfeeding.I am currently being treated with specific medications.I can take care of myself and am up and about more than 50% of my waking hours.I have an active or untreated latent tuberculosis infection.My organs are functioning well.I have recovered from side effects of previous treatments, except for hair loss.I have not received a live vaccine in the last 30 days.I do not have any serious mental or physical health issues that could make this study unsafe for me.I am not pregnant and agree to use birth control during and after the study.I have been diagnosed with a specific type of bone marrow cancer according to WHO or IWG-MRT standards.I cannot take ruxolitinib/fedratinib due to low platelets or it didn't work for me.It has been over two weeks since my last myelofibrosis treatment.I have needed at least 6 blood transfusions in the last 3 months due to low hemoglobin.
- Group 1: Canakinumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the FDA's current stance on Canakinumab?
"Canakinumab has received a Phase 2 safety rating from our team at Power. This means that while there is some evidence that the medication is safe, there is no data yet to support its efficacy."
Are patients still being accepted into this research project?
"Yes, this clinical trial is actively searching for patients as of 7/18/2022. According to the same source, the original posting was on 7/1/2022."
How many people are participating in this test?
"The most recent information available on clinicaltrials.gov suggests that this trial is still looking for patients. The posting went up on July 1st, 2022 and was updated just a few days ago on the 18th. They are only 26 subjects away from their goal, which will be recruited from a single site."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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