Update on progress with MF and the FEDORA clinical trial

[Flyingsteamer]

So to recap, I was diagnosed with primary MF in October 2022 and asked to join a new clinical trial called FEDORA.

After many tests including a BMB, ultrasound on my abdomen, chest X-ray etc. I started on the pre medication of 400mg/day (in one dose) of Fedratinib in capsule form. This was the first 4 week cycle and I am glad to say I had no identifiable side effects. I am prescribed Thiamine tablets as well to maintain my B1 levels.

4 weeks ago I started the second cycle which as well as the Fedratinib now included a two weekly injection of Ropeginterferon Alpha-2b at a dose of 100mcg.

Glad to say again I had no identifiable side effects from the injections so today I started the third cycle and the injection dose has increased to 150mcg. The idea being that with each 4-week cycle the injection dose will increase to a maximum of 250mcg assuming my body can tolerate this.

In this time my spleen has reduced from 8cm oversize to now only 2cm so at least there is some tangible improvement at this early stage. I understand the interferon will take up to 6 months to show some noticeable effects on the Jak-2.

As an aside my WBC has reduced and my neutrophils need to be above 1 to be able to take the interferon so I have now also been prescribed GCF injections (300mcg) to be taken once a week. Yet another self administered pre dosed injection.

I am also having fortnightly red blood cell transfusions (2 units increasing next time to 3 units) to manage my low hemoglobin causing anemia with typical symptoms of tiredness, breathlessness etc.

At some times, usually in the colder weather I am suffering some aching in mainly my leg bones but it is not so bad I cannot move around ok so managing to continue to do some walking exercise and other normal activities.

I am hoping my body accepts the increase in dosage to the maximum so I can get the most benefit from the medication, consultant continues to suggest in the future there is always the possibility of a stem cell transplant which if successful would be the cure.

Best wishes to everyone for the new year, lets keep fingers crossed for more breakthroughs in medical science for our MPNs

Chris

[EPguy]

This is the trial you're in:

ashpublications.org/thehema...

It's only 30pts they say so you're in an exclusive club. Combining the latest in Jak-i's with the latest in IFNs seems a great idea. Wishing you best success in the trial.

Interestingly there was another trial before with the exact same name, but not for a condition we have.

I didn't know there was a way to increase WBC. GCF injections you note seem to be that. I am dose limited on Besremi from low WBC levels. I'm doing ok on blood counts so far, but maybe others with dose limitations and other out of range counts could benefit from this therapy. I don't know if Dr would approve such for PV however.

[Flyingsteamer in reply to EPguy]

Thanks for the link to the trial information, for some reason I had missed that when searching for FEDORA, I am number 001 on the trial so really the guinea pig for it.

[EPguy in reply to Flyingsteamer]

You might have landed on that other FEDORA.

Amazing to be #1. Interesting they max out the Bes at 250. Taken alone it's 500, although I and others here are much less (140 for me, 50 for a few). I expect they are watching very carefully for the effects as your dose increases.

[Flyingsteamer in reply to EPguy]

Yeah, the best thing being on a clinical trial is the attention they give you, there's a very strict plan they have to follow.

[Bluetop]

Thanks for the update -glad it's positive so far. Keep positive and well done!

[Mishie14]

Thank you for sharing. Your experience in this trial is very encouraging! Your courage is showing.

[hunter5582]

Wishing you all the best in treating the MF. It is great that your are willing and able to participate in a clinical trial. This is the only way to expand treatment options for people with MPNs.

All the best to you moving forward.