hi all i have had cll from 2012 i have been on w&w my question is i have signed up for the flair trail Manchester Christie i got phone call this week saying i was randomized for FCR my age is 57yrs i have no tp53 or any other abnormal readings and i dont know what my mutations are etc mutated or unmutated the nurse said she would like me to start next week for fcr i live in a town which is just been upgraded to number 1 for covid i live with my kids and partner some of the older kids work construction there is 10 people in our house at the moment should i be getting a second opinion to leave the treatment for a few more weeks to see how the covid pans out in my area ,,my bloods are heambolign 99 ...wbc 199 ...plts 116..lymphocytes 160 ... just getting a bit concerned about this fcr and infections ,thankyou ,,kel
flair ..fcr: hi all i have had cll from 2012 i... - CLL Support
flair ..fcr
You must phone the clinical nurse or what ever the contact number is and talk this over with the haematology team. They need to know your family situation during these difficult times. Treatment can make you vulnerable to any infection.
Do it on Monday to stop you worrying.
We are not medics so cannot advise on your treatment delay or not.
Best wishes.
thankyou devonr i will do
Hi Kel,
Well first of all you’re joining a good clinical trial in an excellent hospital so congratulations on that. Some places haven’t even restarted Flair trials (including mine, I’m on the I&V arm).
I suspect but can’t be sure that it’s your low haemoglobin level that’s propelling treatment but we don’t know enough about your clinical presentation. Clearly you meet the criteria for the trial. You do need to be speaking to them about your concerns to seek reassurance. I’d expect they have put excellent precautions in place for the day unit with all the Covid protection necessary.
Flair tends to run on a schedule and there is a time limit between randomisation and starting treatment so you’ll need to know what that is if you’re seeking a postponement.
Frankly I don’t think we know how Covid is going to play out over the next few months so it may not be advisable to delay. However, as Devon says, FCR does involve more physical attendance in the hospital and infection is a risk anyway.
Ring the trial co-ordinator tomorrow and discuss your concerns. Explain the lack of physical distance in your home and exposure to others.
Best wishes with your treatment! 😊
Newdawn
thank you newdawn i will phone them tommorow can i ask you newdawn what criteria would you have to be on the flair trial thankyou
Kel, this is the main criteria and I suspect having a haemoglobin level under 10 (signifying possible anaemia) and low platelets may have featured for you. Who referred you to the Flair trial and why did they say you needed to start treatment? Have you been very tired/breathless?
You spleen is normal to slightly small at 10cm (average is 11cm). Mine was 22cm and symptomatic when I started treatment.
Main Inclusion Criteria:
At least 18 years old.
Maximum age of 75 years old.
B-CLL with a characteristic immunophenotype, including small lymphocytic lymphoma
Binet’s Stages C, B or Progressive Stage A
Requiring therapy by the IWCLL criteria in that they must have at least one of the following:
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
Massive nodes (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months as long as the lymphocyte count is over 30x109/L.
A minimum of any one of the following disease-related symptoms must be present:
(a) Unintentional weight loss more than or equal to 10% within the previous 6 months.
(b) Significant fatigue (i.e. Eastern Cooperative Oncology Group PS 2 or worse; cannot work or unable to perform
usual activities)
(c) Fevers of greater than 38.0°C for 2 or more weeks without other evidence of infection.
(d) Night sweats for more than 1 month without evidence of infection.
Considered fit for treatment with FCR as determined by the treating clinician.
World Health Organisation (WHO) performance status (PS) of 0, 1 or 2
Able to provide written informed consent
Biochemical values must be within the following limits within 14 days prior to randomization and at baseline:
Alanine aminotransferase (ALT) 3 x upper limit of normal (ULN). Aspartate aminotransferase (AST) 3 x ULN.
Total bilirubin ≤1.5 x ULN, unless bilirubin rise is due to Gilbert’s syndrome or of non hepatic origin.’
You have to have less than 20% P53 deletion, determined by FISH which you’ve already had tested and established. It’s also important that you’re well enough to undertake the treatment and be able to take medication. If it helps, this is the exclusion criteria;
Main Exclusion Criteria:
Prior therapy for CLL
History or current evidence of Richter’s transformation
Major surgery within 4 weeks prior to randomisation
Active infection.
>20% P53 deletion, determined by FISH
Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies.
Concomitant warfarin or equivalent vitamin K inhibitor
Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment with rituximab has finished, or 30 days after treatment with ibrutinib has finished, whichever is latest. Women must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction.
Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment with rituximab has finished, or 3 months after treatment with ibrutinib has finished, whichever is latest, unless they are surgically sterile.
CNS involvement with CLL.
Symptomatic cardiac failure not controlled by therapy, or unstable angina not adequately controlled by current therapy (in patients with a significant cardiac history the left ventricular function should be assessed and patients with severe impairment should be excluded)
Respiratory impairment (bronchiectasis or moderate COPD)
Other severe, concurrent diseases or mental disorders that could interfere with their ability to participate in the study.
Inability to swallow oral medication
Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease etc)
Known HIV positive
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.*
Positive serology for Hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
History of prior malignancy, with the exception of the following:
Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician
Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease.
Adequately treated cervical carcinoma in situ without current evidence of disease.
Persisting severe pancytopenia (neutrophils <0.5 x 109/l or platelets <50 x 109/l) unless due to direct marrow infiltration by CLL
Current treatment with prednisolone of >10mg/day.
Active haemolysis (patients with haemolysis controlled with prednisolone at a dose 10mg or less per day can be entered into the trial).
Patients with a creatinine clearance of less than 30ml/min (either measured or derived by the Cockcroft Gault formula or alternative locally approved formula).
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
Requirement for treatment with a strong CYP3A4/5 inhibitor or inducer
Cardiac event (eg. recent myocardial infarction, coronary artery stent) requiring dual antiplatelet treatment.
I think you need a sit down meeting with the trial co-ordinator to talk through your issues and ask for the Flair documentation to read through.
Regards,
Newdawn
wow thats alot well i have never had night sweats iam not realy tired iam still working my spleen is enlarged a bit i have had about 15 tubes of blood taken 2 weeks ago no hepitis no hiv no nothing realy i just have not got a clue newdawn i havent lost whieght and i feel i can still carry on but i did have a ct scan and ecg heart no mention of them results,,,i think i need to ask questions ,,thanks newdawn
A normal platelet count ranges from 150,000 to 450,000 platelets per microliter of blood. Yours is a very low 116. Platelets are very important for clotting and to make sure we don’t bleed internally.
Normal haemoglobin for a woman is 12.0 to 15.5 grams per decilitre. Yours is a low 9.9 from what you’ve posted which is becoming worryingly low. Haemoglobin transports oxygen in our blood amongst other things and being depleted can mean our bodies are not receiving the right levels. Can cause fatigue and breathlessness. I’m amazed you are still functioning well!
Do you mean your spleen is 10cm larger than it should be? 10cm is not an enlarged size.
Hope this helps but you need to ask questions and ask for support at the hospital because FCR can be hard going if you’re unprepared.
Newdawn
hi newdawn the spleen size is 8-11 below the left costal margin just checked my results do you think iam getting fcr because my age and i can still work ..thankyou kel..ps it was me who asked my gp for any on going trials for cll do you think i made the right dissuasion,,thankyou
Oh Kel that’s a very big spleen and well fits one of the criteria for starting treatment under Flair which I posted above;
‘Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly‘. Splenomegaly means a swollen spleen.
Yes you sound like you really need to be starting treatment and the arm of the trial is selected purely randomly by computer. Nobody has any input into which of the 3 kinds of treatment you are selected for (FCR, Ibrutinib on its own or Ibrutinib & Venetoclax).
It’s the risk we take on the trial that it’s selected randomly. It’s an excellent trial with very good oversight but I think you need more information and discussion as to what this means to you and your family.
In the U.K., for our first treatment, FCR is usually all that’s on offer if we don’t have the TP53 deletion mentioned so you’d have received that anyway.
You could ask your Consultant about the Acalabrutinib BluMts mentioned but I honestly don’t know if it would be available to you. That would involve taking daily tablets instead of the chemo infusions you’ll receive in the day unit over a 6 month period.
Is there any chance you could get to see Dr. Adrian Bloor there at the Christie for advice? He’s excellent!
Newdawn
yes am under Dr boor so i will ring tomorrow i will keep you informed ,,many thanks ,,kel
I know nothing about FCR except what I've read here and my assumption that it will lower your immune system more than Ibrutinib would. Hence not ideal during this Covid pandemic. Others here will no doubt give you stronger advice than I could.
You sound like a perfect candidate for help from AstraZeneca in getting Aclabrutinib as first line treatment. Free. During the Corona Pandemic I've read that they are offering to arrange this for virgin treated patients whose Doctor has advised them to begin treatment. I guess they would arrange this treatment in a trial setting. The fact that you've signed up to a trial and been allocated FCR may mean they cannot help you... I have no idea.
If I was you I would find out if the AstaZeneca offer still is active. Try to do this on the Internet. If it is, then you'd have to decide how to proceed.
I have to say that I have no details of the AstraZeneca offer and have never been on a Trial, so my comments are not based on experience.
I guess others here more informed about FCR than me, will be replying to you. I hope you come to an easy decision.
hematology.org/covid-19/cov...
Input from Drs. Mazyar Shadman, John Byrd, Michael Hallek, Jennifer Brown, Peter Hillmen, Anthony Mato and Paolo Ghia.
"Are you changing your approach to initiating therapy for CLL during the pandemic?
In areas where COVID-19 is active, it is our recommendation to postpone treatment initiation if possible. For patients who require immediate therapy, we still offer the best treatment option considering disease and patient-specific factors. When there is more than one option, preference should be given to treatments that can be provided in the outpatient setting and require fewer clinic visits and lab assessments. We try to avoid or skip treatment with monoclonal antibodies (rituximab, obinutuzumab) especially when given in combination with targeted agents. Initiation of venetoclax requires multiple and extended clinic visits with lab testing and should be avoided if possible unless considered the most appropriate treatment for a particular patient.
When the COVID-19 pandemic is under control per local authorities, we follow standard treatment guidelines for CLL treatment and would not use COVID-19 as a factor in decision making."
I would phone The Christie and ask to speak to Adrian Bloor. I was in SHH, unrelated to CLL, but they did a chest scan, and found "a significant number of enlarged lymph nodes in my lungs" and " a significant number of enlarged axillary nodes on the left side and some tissue in my left breast which was a cause for immediate concern". I just told them to send everything to The Christie, gave my consultants name, and told them I wasn't willing to be shipped to Macclesfield for a mammogram when I should have had one 2 days before but was in hospital and had rearranged the appointment. Christie were brilliant, really on the ball. They had me in for an appointment literally days after discharge from hospital - SHH had sent me to Wythenshawe for a routine procedure - again not connected to CLL. It went rather wrong and ended up in ICU - not connected to CLL. They also sent everything to Christie, who as I said had me in to discuss things, and arranged a scan for 3 months time, so they knew what was happening. You are in VERY safe hands at Christie.
About to start FCR 
CLL FCR update - 3 years on. 
FCR Bound
FCR + Ibrutinib trial
