Cyclophosphamide in ME/CFS Part A:an Open Label Phase-II Study With Six Intravenous Cyclophosphamide

[BurnA]

Or the trial has had adverse effects and they're stopping early...

The last person would have got treatment in June according to website.

 

[Snow Leopard]

The last person would have got treatment in June according to website.

What I mean is: if they don't think it's a viable treatment due to the side effects, they'd choose not to wait for the follow up and publishing the data they have.

 

[BurnA]

What I mean is: if they don't think it's a viable treatment due to the side effects, they'd choose not to wait for the follow up and publishing the data they have.

I don't think it would be related to side effects.
The only way I could see them changing the follow up period would be if nobody responded or everyone who did respond relapsed within the follow up period.

 

[NL93]

New info

https://helse-bergen.no/seksjon-eng...atment and medical physics/sider/cyclome.aspx

Based on an analysis of the preliminary response and toxicity data from CycloME, part A, we have concluded that in order to extend the trial to include patients with severe to very severe ME, we need to adjust the protocol and plan the intervention and follow-up of each patient with great care. In order to gain more experience with this highly vulnerable group of patients, we are planning a pilot study involving a smaller number of participants. The change of protocol will be subject to approval by the Regional Ethics’ committee and the Norwegian Medicines Agency. We will select candidates for participation in the pilot study from the list of candidates for CycloME part B, and will contact the relevant candidates directly.

 

[deleder2k]

Should be we interpret that as a 40+% response rate in Part A? I do.

 

[A.B.]

In the event that the interim results from CycloME part A should indicate a clinically relevant response/improvement in symptoms in a minimum of 40 % of the patients, the trial may be extended to include patients with very severe ME.

Says so right here.

Why adjust the protocol though?

 

[NL93]

They will also extend the follow up by 6 months.

Status, CycloME part A
The medical intervention phase has been completed, and all participants are now in the follow-up phase.
We have applied for an extension of the follow-up period by 6 additional months, thus completing the trial in July 2017.

We are aiming to publish the results from the CycloME trial, part A, in 2017.

I would guess they have a 40+% response rate, but maybe some participants had some nasty side effects and/or relapses in their disease.
They seem to be taking an extra careful approach with part B.

 

[BurnA]

They will also extend the follow up by 6 months.



I would guess they have a 40+% response rate, but maybe some participants had some nasty side effects and/or relapses in their disease.
They seem to be taking an extra careful approach with part B.

Would the extension of the follow up of part A by 6 months imply that all responders haven't relapsed yet ?

 

[BurnA]

Should be we interpret that as a 40+% response rate in Part A? I do.

I do too.

Why adjust the protocol though?

Maybe the dosage quantity or frequency needs to be adjusted based on their learnings from part A. ?

 

[Mariah]

I would guess that at lest part of modifying the protocol has to do with some severe side effects experienced by some participants, and that they have to be more careful with the severly ill. I know two people who participated. One got so ill she had to withdraw from the study, and another finished it because she wanted to stay true to her commitment, but had no response and also had severe side effects and worsening of symptoms of which she has not recovered from yet. This is not a drug to be messed with, but anxious to see results. I heard preliminiary findings will be presented this fall, but no paper until next year.

 

[Riley]

I would guess that at lest part of modifying the protocol has to do with some severe side effects experienced by some participants, and that they have to be more careful with the severly ill. I know two people who participated. One got so ill she had to withdraw from the study, and another finished it because she wanted to stay true to her commitment, but had no response and also had severe side effects and worsening of symptoms of which she has not recovered from yet. This is not a drug to be messed with, but anxious to see results. I heard preliminiary findings will be presented this fall, but no paper until next year.

How come success stories never make their way to the forums?

 

[Snow Leopard]

I would guess that at lest part of modifying the protocol has to do with some severe side effects experienced by some participants, and that they have to be more careful with the severly ill. I know two people who participated. One got so ill she had to withdraw from the study, and another finished it because she wanted to stay true to her commitment, but had no response and also had severe side effects and worsening of symptoms of which she has not recovered from yet. This is not a drug to be messed with, but anxious to see results. I heard preliminiary findings will be presented this fall, but no paper until next year.

Sad to hear this, but it doesn't surprise me. This drug is known for it's side effects...

 

[Mariah]

@Riley Guessing that those that are better have better things to do than hang around the forums now, don't know ;-). A positive note: My Rituximab doctor had three patients who didn't respond to Rituximab at Haukeland. They all responded to Cyclo, so somebody did respond .

 

[Marky90]

How come success stories never make their way to the forums?

Very few norwegians on this board, and the cyclo-participants don`t talk about it on the norwegian facebook-groups either.

 

[Mariah]

We do talk amongst ourselves though, and word travels. I think that`s a positive thing.

 

[BurnA]

A positive note: My Rituximab doctor had three patients who didn't respond to Rituximab at Haukeland. They all responded to Cyclo, so somebody did respond .

I think this is potentially huge, a second treatment option and another possibility to understand this disease better.

Hopefully they can do enough studies to understand why some respond to rtx or cyclo or none...

 

[Mariah]

Very uplifting yes! And hopefully will lead to even more treatment options for people like my friend who is still worse from the cyclo and who also didn`t respond to Rituxan. I myself did not respond to Rituxan, and my hope is to try cyclo privately within the next year. Think it all depends on when they are presenting preliminary results, so very anxious to find out!

 

[ukxmrv]

Very uplifting yes! And hopefully will lead to even more treatment options for people like my friend who is still worse from the cyclo and who also didn`t respond to Rituxan. I myself did not respond to Rituxan, and my hope is to try cyclo privately within the next year. Think it all depends on when they are presenting preliminary results, so very anxious to find out!

Hi @Mariah,

Sorry to hear about your friends. It was a huge sacrifice for them to be the guinea pigs on this study and we owe them our thanks

How long ago was there last Cyclo infusion and what side effects are they suffering from?

 

[BurnA]

Think it all depends on when they are presenting preliminary results, so very anxious to find out!

Don't Fluge and Mella have some conferences coming up - does anyone expect them to share any details soon ?

 

[Mariah]

@ukxmrv Yes, we owe them a lot. Some of these drugs take huge tolls on the body. I don`t know how much I can speak in detail about this, but since it was an open study, and I reckon none of the participants are on this forum, it`s fine to share a little.

The first friend I mentioned withdrew from the study after I think two infusions. She described feeling extremely nauseas, that her body was on fire and that she couldn`t sit upright most of the time. She recovered from the worst, maybe because she stopped so early. The other one completed the course, and she had the last infusion I think in january. Her reactions was more of a general worsening of the ME itself, she describes being able to take an hour long drive before and after the treatment barely being able to sit up for ten minutes. The stamina was much affected. She also got some extra symptoms and described loosing a lot of hair, which the last one I think is normal with this kind of treatment. I just spoke to her, and she has only now started to improve a little bit, but still much worse than she was. Hopefully she will get back to "baseline".

@BurnA I don`t know anything spesific. The reason I mention this fall is that my Rituxan doctor said that they may be able to offer Cyclo treatment too, but "not before he had seen more data which he expected this fall." So there must be some presentation or preliminary paper or sharing of data on the way?