I'm Interested in the Vanatoclac monetherapy which I am getting right now since summer. I cannot get a straight answer from my oncolog/hematologist at St. Joe's in Toronto or a clinical scientist at Sunnybrook about why I'm getting monotherapy and not dual therapy. I have had fewer side effects than most people on Venclexta get, in fact on any drugs I've taken. I had a short remission after the original obin with a little bit of Chemo. Then took ibrutinib and a holiday after a half year, with no progression. Then acalabrutinib (but only half dose) The half dose was a mistake - I mentioned to the oncologist i was taking 1/2. and she said nothing so that led back to progression of the disease. so I've had what I call one and a 1/2 failures for 2 lines and I still can't get a straight answer as to why I'm getting mono therapy instead of duel because most studies show them Dual therapy gives you a remission that is at least 33% longer than what you get on mono. Does anyone have any information on this? Thank you. This is very disturbing7 to me
Venatoclax mono therapy: I'm Interested in the... - CLL Support
Venatoclax mono therapy
They do not tend to put one on dual therapies if they are in their 70's nor for certain health conditions like kidney disease, etc.
Wow I have minor kidney failure and was given O+V in my 70s..is that a country based statement or world wide?
What we were told is that when one is in their late 70's with comorbidities they are concerned that adding Obinutuzumab or rituximab would probably create more side effects. They left it up to my wife who has a number of health issues and was already having harsh side effects from Imbruvica alone and later with Venetoclax. She opted not to add additional treatments.
I do not think this is a national or state by state or community decision, but I have seen others report the same from their doctors on this site. In addition when one sees the difference in the studies the percentage of advantage with dual treatments did not impress my wife to go for more discomfort. She was on mono Venetoclax for 11 months after 3 months of Imbuvica sequentially and got a 3 year and 7 month remission as a 17P and TP53 patient. That was very satisfactory for us.
RosettaClapp -
I don't think there's an age based guideline.
The FDA package insert warns about monitoring for TLS (Tumor Lysis Syndrome). I think the TLS risk is based on creatinine clearance and eGFR result, as well as ALC, and bulky spleen and nodes.
Creatinine and eGFR vary with age.
mayoclinic.org/tests-proced...
=seymour=
I have cdk and I am on Venetoclax and have had obinutuzimab and Rituximab.
My doctor put me on Venetoclax/Rituximab combination for two years, which I finished in February 23. I am doing well and, hopefully 🤞🏻the remission will last for a long time.
I live in Canada and I had no problem to get the treatment because of my age of 81.
Good luck to sort it out and I would insist on combination treatment personally.
Dana
Thank you. I have had no serious side effects from any drugs except fatigue and no kidney problems. Can i ask what hospital, clinic or specialist you go to? I am 78And still work.
I go to Credit Valley Hospital in Mississauga
Don’t stress .I was on mono veneteclax from April 2019 for 2 years till March 2921 and have been in remission since November 2019.I am under one of the top specialists of CLL in Australia head of the lymphoma dept at one of our biggest melbourne hospitals -v in its own is a brilliant drug -the only thing is that from May to November 2019 once a month I had an infusion of rituximab to potentiate the veneteclax response so are you also getting that-if not request it and hope to are as successful as I have been-still in remission in Jan 2024!
This has also been my experience with what you had - been in remission for over 3 years now
I wonder about differing views of remission. I consider remission without active disease and wonder why people are continuing meds while in remission? I never understood this since IMO there are harsh effects on the body during these treatments. Is there a difference in definition of remission versus NED?
this a wonderful new years report . i am hoping and praying that i have the same amazing results . thanks for sharing . blessings , james
I have been interested in the V with some Rituximab due to the fact I am in remission with Alacabrutinib however still take it. I am a Trisomy 12 with bright CD 20, dim cd38, dim cd 200. Those are my concerns. I still have that bright CD 20 I think the only way to get rid of that is a CD 20 target drug. Plus the cd 38 a risk for RT. I am mutated.
I need to ask you if you were a treatment naive patient, which means that venatoclax and initial doses of rituximab were your first drugs ever to treat CLL. My oncologist says only then is it possible to get those initial doses of rituximab unless you pay thousands out of pocket. What you had is called dual therapy because you got the initial rituximab. Would be useful to know. Thanks roszika and wish you the best of ongoing remission.
Hi- I was only accepted to be dosed with V and R because I fit the criteria of Medicare Australia at the time 2019(The criteria may have changed since then.) First criteria- one had to be over 70 and I had just turned 70. Then one had to have tried chemo which had failed. In my case my previous specialist had me on Leukeran, ( Chlorambucil) on and off- meaning I would take it for a few weeks, stop then the white cells would go up again and I would be back on leukeran. This "yo yo " treatment went on for many cycles until my lawyer daughter said "Mum get a second opinion. Leukeran is deadly, not helping you and can cause problems in the liver and you still have high white cells" I changed to another specialist who did the genetic test which showed I was the ssecond highest risk as I had the TP53 gene deletion. ( this was why the leukeran was not working).There was a third criteria which I qualified with but I forget what it was and it was only then that I was entitiled to be on V and R. The V was $40 a month on my medicare eligibilty and the 6 monthly R infusions were free. Thank goodness for Australia's excellent medicare plan which is open to all Aus citizens. I was on V from April 2019 till end of March 2021 and I was already in remission from Nov 2019. So I was not a naive dosed patient because I had been dosed previously on a chemo. Having failed on the previous chemo drug this meant I could have had V and R. Lucky for me and I wish you the same luck. I am still in remission over 4 years later however my specialist told me that generally remission in patients like me average 3-5 years. Good luck to you
Hi can I ask you if the took them up together which means double side effects or are they taken separately with separate side effects at different times. Thanks again. Your answer means a great deal to me.
I talked to my oncologist about this again. She said that you were probably on your first treatment, which they call "treatment naive" before you started taking it. Wonder if this is true. She also said that she follows Cancer association that supposedly sets the rules in Ontario. I also wonder if this is true. Would really appreciate getting info from you as to whether Venatoclax was your first treatment, and if not where did you get this treatment or did you have to pay for it.(IE. not covered by OHIP) Thanks so much.
I had Obinutuzimab &Chlorambucil as a first treatment and I wasn’t happy with my doctor at the time. With help of these great people in our group I changed the doctor and I feel my present doctor helped me a great deal.
My second treatment wast Acalabrutinib which unfortunately after 8 months of good results gave me permanent atrial fibrillation so it had to be stopped.
Venetoclax &Rituximab was my treatment number 3 and all was covered by OHIP
I had absolutely no problem getting it and now, I am in remission since November 2022.
I truly don’t understand reasoning of your doctor.
The best of luck to you 👋🏻
Dana
Thanks. Can I ask what province you are in? Will convey to my doc.
I am in Ontario
Can i ask which hospital or doc in case i decide to seek a new doc. I will not mention the name to my oncologist. If you prefer.
I am in Credit Valley Hospital
I think you are the second R/R Canadian I've seen on HU that is on Ven mono. BC allows a switch to VenR if poor response to Ven mono but this may be different in other provinces. It looks like they start with Ven mono and then wait for a response.
bccancer.bc.ca/chemotherapy...
Patients may be re-treated with LYVENETOR if they responded to and completed 2 years of LYVENETOR with at least 12 months of progression-free interval (remission).
Patients currently receiving and responding to venetoclax monotherapy (ULYVENETO) but without achieving an adequate response may switch to LYVENETOR. Venetoclax therapy is funded to a maximum of 2 years from the time when riTUXimab is added.
Thanks for this response
Thanks for your response. As for clinical rationale, great idea. They gave me a different type of rational; told me I had failed too many "lines". She cited 4 in a hurried manner. Fact is I failed the first early, older one that was a bit of chemo and obin. Then took ibrutinib with no progression and after a holiday, acalabrutinib. I took just a half dose as acalabrutinib as had been fine with 3/4 dose of ibrutinib. That was not smart but i asked her and she did not object and it eventually led to progression Then was given the mono Venatoclax. I spoke to lead researcher at Sunnybrook and he was okay with me getting the dual since my. Symptoms only to do with bp, but then he found out that she had said no and firmly concluded there was nothing wrong with the mono so I don't feel like I got clear answers.
onu1tadi2 -
> Fact is I failed the first early, older one that was a bit of chemo and obin.
What was the failure? Relapse or side effects?
How was the obin experience?
> I took just a half dose as acalabrutinib as had been fine with 3/4 dose of ibrutinib.
Did you take a half dose on your own, or did the doctor recommend it? Was it due to side effects that you experienced on acalabrutibib? If so, which side effects?
=seymour=
I told the doctor I was taking half the dose. She listened and said nothing --- her usual response. I wanted to take 3/4 dose, but this was given in two pills, not 4. So I am guessing it failed -- ie. progression of CLL. As for chemo and obin -- that was over 5 years ago, and then it was already an older form of treatment, and I am sure, cheaper. I had no side effects. When I started however I was at stage 4. Surprised my GP did not discover I had CLL until stage 4.
onu1tadi2 -
I think maybe your doctor defers to your decision. There's simply not much data on dosage reduction after starting therapy. Most of the dosage testing happens early in the approval process on a limited number of people. They're more concerned about overdose than underdose even then, I think.
=seymour=
If you are still on blood thinners, and your platelets aren't stable, that would be a reason for monotherapy. If your platelets weren't stable when you took obinituzumab, or if you had other problems with the MABs, your doc may think its unwise to restart a MAB. Even if rituximab is used to help with cases of low platelets. Being on Eliquis and venetoclax may be the maximum your body can handle. You can ask your docs.
Thank you. My platelets are stable. On ipixaban and metropolol only, not eliquis. My afib seems be the mild occasional kind. I have had totally normal results each time I get blood test according to the onc/ hematologist. After they gave me their confused rationale my bp became erratic and i could not sleep for 10 days. I felt they were not being honest with me. Are rituximab and venatoclax not given separately? That might not add side effects.
The generic name for Eliquis is apixaban, and since you used the name Eliquis in a previous post I chose that one, sorry for any confusion.
It's not usual to give a solo MAB in CLL, but it is done. Dual therapy is more usual. Canada has it's own protocols for what is given, and when. Even in the US, it's not often rituximab is used solo. And since the most current CLL treatment algorithm recommends obinituzumab as the first MAB used, if someone here were to get a solo MAB I would assume it is less likely to be rituximab.
It's used for certain specific things. One member here has another disease state it also has documentation for helping, so that person is getting a "twofer" for their rituximab, since obinituzumab has no documentation of helping their other disease. My neighbor with CLL had low platelet problems, and had mmm 3? infusions of rituximab before starting an oral agent.
A number of people here have venetoclax monotherapy. The link Skyshark gave above explains Canada's protocol for when to add a second agent.
Please remember researchers are still doing a number of studies to determine exactly how much better dual therapies may be. With us being a rare cancer, the numbers are still small. We don't know yet if that 33% advantage you stated will hold out over time. And for places that have formularies and protocols, it will take a bit of time to get those treatments done in studies, to be put into use.
You can ask how long/what parameters would have to change for your docs to add the R to your current V.
Thank you. So far the difference in progression free results are reported as 33% or higher. Also deeper mrd (minimum residual disease). I now have more to approach doctors with. Their rationale had nothing to do with symptoms and were based on failed treatments, which from top of her head were 3 or 4. Actual fact it was 1 and 1 could say 2 because I took half a dose with her approval. She rarely talks to me in the past 5 years for more than a minute or 2 each time I see her. Best wishes.
Found your choice of words both precise and fascinating. I would be grateful if you could elaborate on something? Instead the current treatment CLL algorithm as though there’s actually a recommended ordered list of treatments to try, and when. Would that be an accurate assumption?! If so, can you please share where a fellow CLL patient my read this for themself? If not, what did you mean by that is very precise wording? Ty. I am currently in watch and wait but my doctor refuses to discuss any sort of treatment, and that is not the way I operate. I prefer to be educated about what is the most common current treatment for the most common that my genetics might suggest. I fully grasp that bodies change, bloodwork changes and treatment change, but I can only educate myself on what is current, not what is not here yet! Thanks for any education or answers to this
I am not sure what your statement means: "Instead the current treatment CLL algorithm as though there’s actually a recommended ordered list of treatments to try, and when". So I am guessing with my answer.
Figure 3 in the link below shows the current treatment algorithm recommendations. It's relevant to *previously untreated patients*, not all patients. The only MAB currently recommended for *initial* therapy in treating CLL is obinituzumab, and it is recommended to be used in addition to another agent, if you are going to use it.
When multiple therapy choices are listed in a box of the chart, it means "there's no clear preference which order to try". If there was a clear preference, a therapy would be in a box by itself, before the chart then displayed another therapy in its own box.
Pretend the things in parentheses are the boxed items in a chart So "If (X), do (A or B or C) means "either A or B or C" is recommended. Otherwise the chart would read, "If (X), do (A) then (B) then (C), and each of the three (A-C) would be in its own box. A list of treatments inside the same box, means "select one from the list, there's no clear preference". The chart does note "preferred treatments are in bold" because there happens to be one. Things like adding a bolding from a list are done, instead of rewriting the entire chart as new data comes up, because it's easier. At some point the chart will be totally redone, and new boxes for saying if A, B, or C is better to try first will be added, if there is data to support the change.
nature.com/articles/s41408-...
This being said, it's not necessarily "wrong" for a doc to decide their specific patient needs a modification for initial treatment. If a doc determines it's in their patients best interests, these guidelines aren't set in stone. And it also wouldn't be wrong if a patient wants to question why a doc isn't following the guidelines for initial therapy.
Countries like Canada and the UK may have modifications or recommendations slightly different, to be used in that country. In the US, large healthcare organizations may have a formulary preference. So the Veterans Administration, or Kaiser Permanente, may have internal guidelines they follow.
For relapsed treatment of CLL, there isn't a general consensus for any specific treatment over another.
BC cancer doesn't seem to have an algorithm. Plenty of protocols.
Anon2024 -
There are country-by-country (well, also EU) treatment algorithms, and there is some flexibility at each stage of treatment. In the U.S., the NCCN (National Comprehensive Cancer Network) sets the algorithm. All the major research cancer centers belong to the NCCN, and it affects things like insurance reimbursals and FDA approvals as well. It's updated several times a year. You can download patient guidelines for each type of cancer, or create a free patient account and download the physician guidelines. But it's really heavy reading.
nccn.org/guidelines/guideli...
Studies usually last several years, and often have annual statistical updates published that help determine algorithms and which treatments are approved. The population in the studies varies, and I find it's hard to pinpoint myself with my markers and comorbidities (or lack of) in the studies.
I think it's best to get a second opinion from a CLL specialist just before treatment. In the U.S., you can get a free Expert Opinion:
cllsociety.org/programs-and...
=seymour=
I should have stated I was referencing the overall "international" algorithm, and various countries take what they will from it. I think of it more as "this is what the data worldwide overall shows, regardless of local factors." Then each country/region has to take factors relevant to that region, when making decisions for their particular patient group. Which a doctor then does at an even more individualized level.
I was on Venetoclax/rituxan for a year and so far have been in remission for five years. I am 72.
Thanks fir the information. Can I ask what treatments/drugs you were on prior to the dual therapy. Apparently the fewer previous drugs you have been on helps increase the success of Venatoclax dual therapies.
Hi Emmiekay, That's great to hear you have been in remission for 5 years, long may it continue. sorry to jump in on this but I was just wondering if you are Mutated or Unmutated? Thank you Sue x
Hi Sue, I actually have no idea. It doesn’t specify that anywhere in my test results. I suppose I should ask next time I see the doc.
Actually I find they are less forthcoming in that case. Nonetheless, I agree that not only see the question be asked but you should demand getting an answer that you fully understand its rationale. Ask the question as many times as you need, but be prepared that you might have to find a new doctor if they still won’t communicate properly, and or ban you from their practice at some point which many doctors do nowadays because while the profession has changed, their arrogance hasn’t, for many. Gl. If you know the dual combo like the name of the treatments you think is better, why don’t you specifically ask if there’s a reason why you can’t try that instead? Is your body. You know your body and mind better than any doctor ever will.
They talked about "lines" of treatment. She answered my question about why I am on mono, with a garbled explanation about having failed too many lines of treatment. But I looked up the government suggestions on how many failed lines OK, it it said 3. I have failed one, the first one, and the second was the one where I took the half dose. No others, so only2. The head clinical trial scientist I asked at the Sunnybrook, who I had met twice, said no problem with dual therapy, even with 4 lines previously, but half way through the phone discussion he abruptly changed his tone --- said mono was just as good, that hard to tell...very mysterious.
I am a bit confused about the garbled "lines of therapy" failure having anything to do with monotherapy. I'm not in Canada or the UK, where *those places* have their own algorithm recommendations nationally, that they have decided on. So if your country or region does this routinely for everyone no exception, there may not be a way to counter.
I do know that within the CLL research community, it was originally thought when the BTKi's came out, that patients would switch from short term regimens that included standard chemotherapy drugs, to permanent oral agent (in this case, the BTKi).
Then the problem of relatively rapid BTKi resistance appeared. So more studies were started and are still being done. Is one, or 2 or 3 agents best? And for what patient group? Because now that CLL is showing up in younger and younger patients, why should those be handled the exact same way as an older patient? In other disease states, younger patients may be treated a bit differently than older ones.
Not to mention, what does the patient want? Do they want to try for a cure, or are they OK with just "managing" symptoms? Because the treatments involved are very different.
And if prognostic markers/mutations that have historically affected outcomes are in play, to what extent will that affect things? It's all very complicated. And there are very few clear cut, decisive answers. It was a revelation to learn the distinction of mutated versus unmutated with respect to IVGH and standard chemotherapeutic regimens, but I am not sure there are a large number of profoundly relevant other "statements" that can be made. The first one that comes to my mind is "don't use ibrutinib as a first line treatment in patient with known cardiac arrythmia problems".
Can't say for Canada but here's some examples from UK and NHS. All are out of date as Ven+I and Zanu have been added this year. Ven+I is 1st line only, an alternative fixed duration treatment to Ven+O. Like all BTKi Zanu is 1st line for del(17p)/TP53mut and those unsuitable for FCR [1]. It's 2nd/nth line for everyone including those intolerant to Ib/Acala until progression on BTKi.
This is because approval is based on evidence and a lot of trials are for treatment naive, not R/R. Because of this re-treatment with Ven+O isn't available and Ven+R isn't first line.
BSH, table 1 (image) also BOX 1 for 2nd line.
onlinelibrary.wiley.com/doi...
Royal Surrey algorithm.
royalsurrey.nhs.uk/download...
Clatterbridge (Liverpool) 2nd line.
clatterbridgecc.nhs.uk/appl...
[1] I'm beginning to suspect that UK doctors are now avoiding testing for IgHV status. Today I asked for my IgHV, FISH and NGS results, they where unable to supply IgHV. If IgHV status is unknown they can't be placed on the left of the algorithm with potential FCR. If the doctor doesn't know they can with clear conscious tick the box on the "Bluetec" form for cancer drug funding that says "unsuitable for FCR". Anybody asks they can say "I didn't know the IgHV status, so assumed the worst" and point to studies that show FCR is unsuitable for IgHV unmutated.
TBH, and based on your comments. You need a second opinion from a CLL specialist.
I have just started Venatoclax. First week 20mg rising to week 5 100mg. This is to get my body used to it. Also taking antibiotics, and antacids. Will let you know what happens after the 5 weeks. Feeling slightly sick, but have medication for that too.
Sorry don't have an answer for you. Really not right that no doc will sit down and tell you the reasoning. Whatever it is, I'm under the impression it's their duty to let you know what and why. At some point, I might get a bit firm with the doc about it
Yes, I agree. I left a doc who refused to answer a question I had, why a protocol was not being followed. I think it was an error, which would have been no big deal to me. Fix it & move on, it happens. I of all patients would be one of the least likely to cause a fuss for a random human error that wasn't significant overall. But they refused to acknowledge/discuss/own it, so I left.
I have been taking Venetoclax only for a year and I have done great on it. I rejected the Obinatuzumab because of the immune suppression it causes for a year after you stop it. Maybe your doctor doesn't want you to have that immune suppression that's caused by it. I also did not want the extra toxicity.
I started Venetoclax monotherapy in one of the earlier clinical trials and continued to take it for over 5 years with continually good bloodwork. I achieved uMRD a year and a bit ago and am currently not treating my CLL. I did a great job for me. I understand that combo treatments have great results too.
DX'd 2006, Trisomy 12 mutated, 4 different lines of treatment.
Take care.
Are you possibly running through the CLL options "too fast"? There are great options, but a limited number. My Dr. advises to stick with one therapy as long as it works, do not change easily. Eventually, it may stop working and that is when to change. We need to play this for the long game. PS: I deleted an earlier reply, and I apologize if it was written too hastily.
Actually no. I was in remission and a drug holiday 6 months after ibrutinib, but because of its cardio toxicity Doc and I decided on acalabrutinib after holiday was over. I was still in remission. I did make a terrible mistake though by only taking half doses (3/4 doses worked fine with Ibrutinib, no progression.) So the acalabrutinib "holiday" led to progression. Then went onto Venatoclax. I have had no serious side effects from any drugs except for the onset of afib.
As per Canadian CLL guideline recommendations:
Patients with CLL demonstrating progression on continuous BTKi should be switched to venetoclax + /- R (Category 2A)
sciencedirect.com/science/a...
Perhaps your Dr. is not adding R because you relapsed on Obin in your first line.
They are both monoclonal antibodies (anti CD-20 drugs), with Obin being superior to R.
Not what you're looking for?
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