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CLEAR trial

Topic Made On: May 20, 2011 10:30pm
Nick

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CLEAR: CLL Empirical Antibiotic Regimen - A phase II trial of broad spectrum antibiotic therapy for early stage, non-progressive chronic lymphocytic leukaemia without adverse prognostic factors

This phase II trial is testing the use of antibiotics for patients with chronic lymphocytic leukaemia who have received no prior treatment. Patients will receive a short but intensive course of antibiotics, to help control the symptoms of their disease, early on.
This national trial is being run by Dr Stephen Devereux at King’s College London.

Does anyone have any links to studies or research documents explaining the rationale?

My limited understanding is that the trial is effectively investigating if infection drives CLL progression during the earlier stages of the disease..

Nick




Replied On: May 26, 2011 09:36pm
Nick

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Following on from the many questions I had regarding the rationale involved in the UK CLEAR trial, CLL Empirical Antibiotic Regimen

Cheya has posted her understanding/take on the trial in CLL topics tidbits, which helps explain the theory behind the study.


http://updates.clltopics.org/tidbits-archive-index

I too have questions as to why anti virals are not included, but can see that it may not be such a great leap to take to believe common, underlying bacterial infection may be sufficient to drive CLL during the early stages of CLL. This is a simple study but may provide some tangible results.

At the UK CLLSA annual regional meeting yesterday, DR Ben Kennedy touched on the potential for this process occurring, his Afternoon CLL presentation to the forum covered much new ground and was the best overview presentation for CLL patients I know of. I hope his slide show will be made available to us. A man of extraordinary humanity.

nick



Replied On: May 27, 2011 01:59pm
Nick

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Maybe the thinking is in here?

2008
A new perspective: molecular motifs on oxidized LDL, apoptotic cells, and bacteria are targets for chronic lymphocytic leukemia antibodies

http://bloodjournal.hematologylibrary.org/content/111/7/3838.full.pdf


There are many "factors" that together may contribute to the development of CLL, not least our individual propensity for any one or the combination of some of these to be part of the trigger?

Perhaps my thoughts are centering around the theory that the continued presence of pathogens may continue to fuel CLL development, driving CLL advancement? Any thoughts?



Replied On: May 28, 2011 08:50am
Domineys

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Nick, Thanks for your posting with the link to http://updates.clltopics.org/tidbits-archive-index It led me to Harvey's Journal by Cheya. I spent all morning reading it - not comfortable reading - but it answered a lot of questions about stem cell transplants. I have an appointment at Southampton General Hospital (UK) on Tuesday 31/05 about my suitability for a reduced intensity matched unrelated donor stem cell transplant. I am 69 (already!)but pretty healthy apart from CLL. My husband will be reding the journal this weekend. I has clarified my thoughts about questions to ask - many thanks. Ann




Replied On: May 31, 2011 12:04pm
Nick

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Ann, Glad you found Chaya's writing of help. Good luck with your meeting today, keep us posted.

there is a meeting of the CLL Support Association to be
> held on Friday 15th July 2011 from 11.30 to 16.00 hours, at Southampton
> General Hospital, SO16 6YD

> This meeting is special in that as well as meeting other members and
> discussing experiences with CLL you will be able to hear the speaker, Dr
> Duncombe, a consultant with a special interest in CLL who will be talking
> about his speciality, drug trials for CLL.

Ann this may be an oppertuntity to meet a sucessful transplantee locally, Chonette Taylor a CLLSA trustee spoke at the last meeting on transplants, I'm not sure if she is speaking at this meeting, but she will be there in attendance for us. There are a limited number of places available. I don't know if this is your bag, but Chonettes experiances and opinions are not sugar coated.

Nick

PS:
> Limited to 35 places; attendance is free to members and their carers.





Replied On: Jun 19, 2011 06:33pm
Domineys

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Nick, Thanks for this information. My meeting at Southampton general went well - 1.5 hours with the consultant! She explained the stem cell transplant process in detail. Cord cell transplants (as in Chaya's writing) seem to be in their infancy in the UK and I would be considered for an unrelated donor transplant. With worldwide registers to be consulted, she extimated the chance of a match to be about 70%. On the downside, at age 69 the risks in having a transplant would be much higher than in a younger person - about 50/50 chance of long-term survival.

Much would depend on the biological, rather than chronological, age of my organs and whether my current treatment with Campath (Mabcampath) gives a "full"remission. If these things were in my favour and a suitable match found the transplant proposal would have to be approved by the Transplant Commissioners for the South West. I was assured this would not be a financial decision, but I remain sceptical! Meanwhile, the process to find a match has been started.

Altogether there would be a great deal to think about before making a final decision to go for a transplant and my husband and I have decided to take one step at a time. Not everybody can withstand a full course of Campath. I have had my escalation week - building up from 3mg to the full dose of 30mg. This involved, as it turned out, 9am to 5pm as a day patient from Monday to Friday last week. Side effects can be serious so much of the time was for monitoring. I had two side effects, sickness and shivering, on the first day which were quickly controlled by medication. Because of this I had to repeat a day with the lowest dose on Tuesday - no problems. Wednesday the dose increased to 10mg - no problems. Thursday saw the full dose and, having had no problems the two previous days I looked forward to day off on Friday! However, I had a reaction, this time hives - an irritating rash - again quickly controlled by medication. I had to repeat that dose on Friday and again reacted with hives. However, with the same dose on Monday this week, and piriton tablets taken over the weekend, I had no reaction and the same again on Wednesday and Friday - so far so good! I also had to have three units of blood, so again it was a busy week. I'm feeling positive about the treatment this week.

Sorry to go on, but hope this might help anybody facing Campath, although, of course, we are all different!

Best wishes to all, Ann



Replied On: Jun 21, 2011 03:00pm
Nick

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Hello Ann,

It was good to read your writing. I think it will help many, not just those considering Campath and the possibilities of transplant. Well done.

Wishing things go OK this week and you gain a good remission. take care.

Nick



Replied On: Apr 10, 2012 01:13pm
lesleyandrea

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Hello

I see you posted a small mention about the CLEAR trial at Kings College Hospital. I have been asked by my own consultant if I would like to take part. Possibly because my own WBC is going up in leaps and bounds and they're not quite sure what else to do with me!! Is anyone out there currently taking part in this trial? If so have they received any benefits apart from the fact you may be aiding research for CLL patients of the future. I'm worried that by dosing my system whith huge amounts of strong antibiotics I may be storing up trouble for the future with my already weakened immune system.
Any feed would be greatly appreciated in helping to make a deision.





Replied On: Apr 10, 2012 02:48pm
Nick

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Hi Lesley.

I have followed the CLEAR progress the trial was delayed in set up for a while.

One thing to bear in mind is that the trial is for those with early CLL with no adverse prognostic indicators and symptoms. The fact your GP has included you may be an encouragement.

I am not sure if test results involved in the screening process will be available to candidates?

From what I understand and remembering how the late Terry Hamblin answered my queried is that it is a low cost trial to find out if underlying bacterial infection drives CLL progression. I think the benefit is provision of data. When the trial is over the antibiotics and discontinued any advantage I would guess will be no longer? Perhaps a personal choice and several leaps of faith are required to aid in research?

I was still awaiting the start letter through the post (that is if I still qualify?), however I am about to start cardio rehab and have been told they won’t proceed with an exercise plan while I am on antibiotics? Perhaps co morbidities and other issues also need considering?

Personally at the moment I would welcome any support from antibiotics to give me a good clear out as I am about to start another course of Augmentin to remove an underlying infection anyway. However heart recovery following an MI will take precedence over any contribution to science. ( :

Not sure this is of help?

Nick



Replied On: Apr 11, 2012 05:14pm
lesleyandrea

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Hello Nick

Many thanks for taking the trouble to reply and certainly that agrees with the little information my current consultant has given me. In laymans terms the thinking is that CLL is caused initially by an infection - and I can certainly agree with that as I had the mother of all infections just prior to being diagnosed - and by giving broad spectrum anti biotics they are hoping to see if they can wipe out the initial infection.

Today I have been told of a friend of a friend who is actually on the trial at the moment and is supposedly feeling much much better but to be honest I dont really feel 'ill' as such although I could do without the constant hot sweats which seem to be on a continuous loop. Although when I read some of the other posts I realise how lucky I am. I'm going to speak to this lady this evening to see what her take is.

Thanks again and take care.

Lesley



Replied On: Mar 08, 2017 01:21am
Yanni

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Hi everyone
Does anyone know what happened with this trial, it appears it has disappeared from the radar and cannot find any results either.
Regards Yanni



Replied On: Mar 09, 2017 10:28am
Yanni

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CLL Empirical Antibiotic Regimen (CLEAR) Trial. - UPDATE MADE CONTACT WITH THE RESPONSIBLE PERSON - Dr Stephen Devereux, King's College Hospital NHS Foundation Trust. Here is his reply ..."Thanks. The trial closed and we are currently analysing the data. We expect results in a couple of months
Regards
Stephen Devereux"...
I also offer to share my experience with his students and himself. Nice of him to respond so quickly, let us all hope that good results come out of the trial fingers crossed. https://clinicaltrials.gov/show/NCT01279252



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