Time for treatment decision

[harley2018]

Hello everyone! Weekly I have read post after post and learned alot from you all. I was diagnosed June 2017 and have been in W&W up until now. I am a patient at Duke in Durham,NC. Today my specialist told me I was ready for treatment and offered me a trial they are currently running. There is a 50/50 split where 320 patients get obinutuzumag (gazyva) and Ibrutinib (imbruvica) and the other 320 patients get these two drugs along with venetoclax. I’m so confused on what to do. If I choose to not partake in the study I will get obinutuzurnab and Ibrutinib. Can any of you tell me your experiences with theses drugs or if they offer this sort of trail in your area. I’m scared, confused and not sure which direction to go in. Thanks

[Spacee]

Hi Harley. I am going to guess that you are 17p-. And would not respond to Chemo. My hubby is 17p- and for that reason, not given it. I am a non practicing nurse. But I read a lot of the posts when he was first diagnosed and I had decided that the drug of choice would be Venetoclax OR Ibrutinib...depending on doctor’s choice. Then he was offered a trial. Different than yours. Not one group against another group. Just one group. On Keytruda and Ibrutinib. He has done fine. But I would have felt ok with just one or both. OR your two choices (the 2 verses Venetoclax). With these really good drugs, there is time down the road to make changes. These drugs are that good. It’s a really good time for us all.

Stay strong!

Linda

[harley2018 in reply to Spacee]

Thanks so much! I worry greatly about side effects too. Mainly gastro issues and Afib. Happy to hear your husband is tolerating treatment well.

[Spacee in reply to harley2018]

Neil has so much more to offer about Venetoclax. Seems to be a great choice. Side effects for hubby have been some fatigue, diarrhea but controlled with Imodium and yogurt (taken separately. No a fib. He is already on a blood pressure med so that might help. He is 72 and still works part time.

His trial you only have to have a white count of 100,000. His was 95,000. So they had him climb a few flights of stairs and it did the trick. The goal is to see if you treat a person who has few symptoms of CLL (early in the disease), if it will do the trick better of keeping the illness at bay. We will see! I have high hopes.

Linda

[AussieNeil Administrator]

That's a great trial to be on. I'm on a similar trial, where Acalabrutinib is used in place of Ibrutinib and Venetoclax is available in both arms and Gazyva available in just one arm. I am in the arm with Gazyva. It's done a great job of clearing out my bone marrow, lifting my platelet counts by nearly 100, plus reversing my anaemia and almost removing my need for G-CSF injections.

I'd suggest going on the trial so you have a 50% chance of gaining access to the Venetoclax arm, simply because Venetoclax is capable of getting you to U-MRD on its own, plus you have better monitoring.

Neil

[harley2018 in reply to AussieNeil]

Thanks so much. WBC is 85,000, platelet 125, hemoglobin 12, and hematocrit 39.3

[AussieNeil Administrator in reply to harley2018]

Thats pretty good, as you have plenty of leeway for any bone marrow suporession. Presumably your neutrophils are good too.

I misread your post and hadn't appreciated Venetoclax is only available in one trial arm. I've revamped my answer above accordingly and would encourage you to go for the trial to see if you can get into the Venetoclax arm.

Neil

[Smakwater in reply to AussieNeil]

I see a bicycle in your future.

[cajunjeff]

I like all your options. My pick would be ibrutinib plus obinutuzimab outside of the trial. That gives you and your doctor the most flexibility to add and subtract drugs as we learn more about the various combinations. I wouldn’t argue with you if you picked the trial. Hard to go wrong with your choices.

[Doggoneit101]

Hi Harley,

I've done Ibrutinib in the past and had to be taken off. The diarrhea was relentless so my dosage kept getting lowered. Then I got C-Diff and started having chest pains and I was immediately taken off due to family history of heart problems. I was switched to Venteclax and have been on it for 2 months. I have not had one single problem with Venteclax. My bloodwork is getting better every visit. Good luck in whatever treatment you and your specialist decide to go with. Many great treatment options these days. You just have to find the one that fits for you. Stay strong and positive

[harley2018 in reply to Doggoneit101]

Thanks so much. I worry about the stomach issues as I already have a very bad stomach (IBS) to start with. I shared my huge concerns with my doctor about Afib because every member of my family on one side has heart problems including Afib and heart attacks with two dying as a result of heart failure. She assures me that it should not be a problem due to my age but I am having heart tests done prior to treatment. I’m still uncertain if I will go with the trial. Honestly I prefer to not take Ibrutinib and take the Acalabrutinib instead. Is venetoclax given by itself or in combination with something else. It seems all patients still have the 6 month iv treatment at the beginning, all confusing to me!

[Doggoneit101 in reply to harley2018]

Before I started Venteclax I had to take Allpurinal for a month . It is given to protect the kidneys and it lowers uric acid levels and help prevent tumor lysis syndrome. After a month of that then I started the Venteclax. My oncologist preferred me to come in to her office early every morning to get IV fluids and bloodwork to make sure I was not getting tumor lysis syndrome. I'm glad that she didn't make me go in the hospital because I'm sure I would have picked up something in the hospital. Many oncologist require patients being hospitalized during the first week. I didn't have the 6 month IV treatment. Venteclax is a oral pill that is taken in a ramp up. The dosage increases from ex. 25 mg up to 400mg. The only problem I have had this far is with the Allpurinal. It caused a horrible itch! It made me feel like I rolled around in poison ivy. I expressed my concerns to my oncologist and I had to continue taking it till I finished my ramp up. Other than that my bloodwork is looking much better! Hope this answers some of your questions. Good luck in whatever treatment option you decide.

[harley2018 in reply to Doggoneit101]

It helps a lot. Thanks so much and best of luck to you!

[harley2018 in reply to Doggoneit101]

Oh one more question if you don’t mind. I was told the first and maybe second month of venetoclax required 3-5 day hospital stay. Sounds so serious

[booper57]

Hi Harley,

I also was diagnosed with CLL in June of 2017. I was put on W&W and informed by my CLL specialist that because of my makers I would need treatment sooner than later. In Oct of 2019 I started a trial of O&V. Greatest decision I've ever made. I went in very scared like you. My doctors feel very confident at year end I will be MRD. I have had very minor side effects with the Venetoclax. Slight headaches and nausea. I was given Compazine for nausea which helps very well. Good luck to you in whatever you choose.

[harley2018 in reply to booper57]

Thanks so much. I feel comfortable with O and V. It’s the Ibrutinib that scares the mess out of me. For three months I will get all three drugs. Of all I’ve read so far venetoclax is awesome! So happy to hear you are doing great! Gives me hope.

[Smakwater]

harley2018,

I'm not qualified to recommend cancer drugs to patients. I just wanted to let you know in a nut shell that my experience with obinutuzumab and venetoclax within 11 months produced a CLL clear bone marrow biopsy and normal nodes.

Although initially I had some expected reactions with the obinutuzumab and some mild neutropenia later on from the venetoclax, the combination was very tolerable.

I benefitted much more from the therapy than I suffered side affects. The more defined conversation for choice of therapy of course will be with your doctor.

Congratulations on acceptance into the novel therapy trial.

All the Best, and thank you for participating.

JM

[schmitthj007]

Harley

I am in a similar trial and can only recommend it. Would take the chance to get venetoclax since this can get you to MRD-u. Neutropenia is a common side effects but with prophylaxis infections are surprisingly low. I am in Bactim three times a week and acyclovir. Also received both shots for pneumonia and immunization for shingles prior to starting treatment.

[aquafinn]

I think you are talking about the trial that I am on. EA9161 This trial has been phenomenal so far. I am starting the 4th cycle (every 28 days is a cycle)on Tuesday. My blood work is all normal! The patient care I have received has been wonderful. The drugs are all covered by the clinical trial but nothing else. My insurance has picked up the rest. Not cheap by any stretch but certainly less expensive than if I were not in a trial. I also get an enormous emotional boost by knowing that I am involved with a clinical trial. I believe clinical trials are where we will finally cure - (yes I used the word CURE )this beast!

[harley2018 in reply to aquafinn]

This is awesome. How have your side effects been since being on all 3 drugs starting the 3rd cycle.

[aquafinn in reply to harley2018]

Not bad side effects. I work full time at an elementary school and I have not missed a day except for the infusion days of course. I had neutropenia in the beginning that made me miss one obintuzinab infusion and Ibrutinib for a week but my body recovered in less than a week without any intervention.

I have felt a little nauseous and dizzy for a few days after adding the venetoclax and every time they ramp up. If I take a zofran (I was given at beginning of trial but hadn’t needed) I feel fine. I have been constipated off and on but I’m not sure if it’s the venetoclax or zofran or a combination of the two. ( I hope this isn’t TMI!)

[harley2018 in reply to aquafinn]

So happy you have done well. My two fears are Afib and stomach issues as I already have a bad stomach (20+yrs of IBS). There is a 50/50 chance I’ll get venetoclax with Ibrutinib and obintuzinub other 50% don’t get venetoclax. If I do not get the trial I have 100% chance. I’ll get obintuzinib and venetoclax. Was it emotionally difficult for you to chose the trial? I’m scared. I guess bottom line is I want treatment that I don’t have to take lifetime with the most minimal side effects. I’m am so happy to hear your experience has been great.

[aquafinn in reply to harley2018]

I know truly what you are going through. I really wanted the venetoclax arm and realized that it was 50/50. The thing I made sure of was that if I was randomized for the ibrutinib Obintuzimab arm that at any point if the ibrutinib side effects got too much I could stop and it would not preclude me from getting venetoclax at that point or sometime in the future.