A071402 Phase 3 clinical trial - Obinituzumab+Ibrutinib+Venetoclax

[Iupiter]

Hello, I’m new to this forum. I am 74 year old male. I was diagnosed with CLL in April of 2019 but was told that most likely I had had it since approximately 2015. It was RAI 1 at that time. A few months ago, I had both CAT Scans and PET Scans and was told by my Dr that I needed to start treating my CLL. He recommended that I take part in a clinical trial A071042. I stared this trial 5 weeks ago. Day 1 of cycle 1 I was infused with 100ml of Gazyva or Obinizutumab and given 420mg of Ibrutinib. The next day my blood test showed that my liver markers had gone through the ceiling. Then day 2 of cycle 1 I was not given anything while my Dr figured things out. The conclusion was that it was the Ibrutinib that had affected my liver, not the Gazyva, so day 3 of cycle 1 I was infused with 900ml of Gazyva but not given any Ibrutinib. We waited 3 weeks for my liver markers to return to normal, then 2 weeks ago I was re-started on 140mg of Ibrutinib daily. During that time, on days 7 and 14 of cycle 1 and on day 1 of cycle 2, I was infused with the 1000ml of Gazyva prescribed in the trial. Last week since my liver markers were still OK, I was upped to 280mg of Ibrutinib daily. Tomorrow I am to go and have one more blood test. If the liver is still OK my Ibrutinib will be increased to 420mg of Ibrutinib daily, which is the amount prescribed in the trial. I would like to know if there are other people in the forum who are in the A071402 clinical trial who would be willing to share experiences in the coming 14 months with me. Also, I would like to know if anyone had an adverse liver reaction when they started the trial. My Dr says that neither he nor the medical directors of the trial had ever seen this reaction. Thank you.

[Smith123456]

i'm on all 3 -not on a trial. just finished gazyva a month ago. never any liver issues. i'm 70

[lankisterguy Volunteer]

Hi lupiter,

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I found this trial on clinicaltrials.gov/ct2/show...

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The ClinicalTrials.gov Identifier is: NCT03737981

and some of the other numbers are:

A041702 ( Other Identifier: Alliance for Clinical Trials in Oncology )

A041702 ( Other Identifier: CTEP )

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Here is a list of 33 previous postings where I+V+O is discussed. You may want to scan through them to see if your question was answered.

healthunlocked.com/cllsuppo...

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And you can find some interesting past postings by looking at the box on this (and every future page with different titles), labeled: Related Posts

*Venetoclax Clinical Trial

healthunlocked.com/cllsuppo...

*Venetoclax Clinical Trial - Month 3

healthunlocked.com/cllsuppo...

*18 month Follow up results with Ibrutinib/Venetoclax clinical trial

healthunlocked.com/cllsuppo...

*New Clinical Trial of Ibrutinib + Venetoclax for people relapsing on Ibrutinib

healthunlocked.com/cllsuppo...

*FLAIR trial Venetoclax and Ibrutinib update healthunlocked.com/cllsuppo...

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Len

[Iupiter in reply to lankisterguy]

Thank you Len. What is the Volunteer label next to your name supposed to mean?

[lankisterguy Volunteer in reply to Iupiter]

It means I am one of the 9 people that moderate this site.

If you follow this link- we are all listed at the bottom of the page healthunlocked.com/cllsuppo...

Len

[cllady01 Former Volunteer]

lupiter: the following information is a study of reviewed cases regarding Ibrutinib and liver changes. You might be well served to share the article with your Dr.

I would not venture to say you have liver damage, but I would suggest you need to know if the Dr. has tests evidencing no liver damage. It could be a fluke that this happened, but I would do my best, were I you, to be assured the following information and case study is known by the Dr.

Also "Concomitant medications"---all meds you are taking need to be cleared with the Dr for any CYP3A inhibition--foods that are to be avoided are important to for this very reason of inhibiting CYP3A (Grapefruit, Seville oranges/marmalade, kiwi fruit are some to avoid).

ncbi.nlm.nih.gov/pmc/articl...

"Increased liver damage from ibrutinib will occur if not detected early, since it is metabolized in the liver by the P450 cytochrome enzyme CYP3A [16], and, therefore, drug levels will rise once liver damage has commenced. The manufacturer recommends dose reduction in patients with known mild liver disease or concomitant medications which inhibit CYP3A and complete avoidance in patients with moderate to severe liver disease. Fortunately, the liver damage abates after the medication is withdrawn, but continued drug exposure may lead to serious liver failure. All patients treated with ibrutinib should be monitored periodically with serum liver function tests and the drug discontinued immediately if there is no other apparent cause for an elevation."

PLEASE let us know how your appt. goes.

[SandandWind]

I am half way through a phase three trial with this combination but for people under 65. I have not had severe liver problems. I am glad to answer any questions you have.

[Iupiter in reply to SandandWind]

Hi SandandWind! You say had no severe liver problems, but did you have any liver problems, maybe not severe ones? How did things go when you started on the V? (I should be starting on the V in a couple of weeks). Thank you.

[SandandWind in reply to Iupiter]

No liver problems at all. Venetoclax went fine although I ended up dropping to 200mg dose after neutropenia. My understanding is the plan is to keep it that way through the end of the trial. On the reduced does have been fine.

[Iupiter in reply to SandandWind]

Thank you S&W. I just read all your previous posts and found them very helpful. (I'm new to this, so I am slowly learning how to work the website and find more information). I especially appreciate your advice about the water after starting Venetoclax, as well as how the ramp-up goes, as I will soon be starting that part of the treatment. I hope everything continues well for you!

[SandandWind in reply to Iupiter]

I am glad they were helpful. Water and walking continue to be key for me. I find if either one gets short changed that I can feel off. I hope your ramp up is easy on you. Best wishes!

[ttomo]

I completed this trial in August at which point I was UMRD and able to discontinue the trial drugs. I am always available for any questions you may have. I had no issues with liver function. I wish you well as you continue the trial.

[Pacificview in reply to ttomo]

What does it cost the patient for being in the trial???

[Iupiter in reply to Pacificview]

The only thing covered by the labs participating in the trial with their drugs is the cost of the drugs. The drugs are by no means cheap. This means that you have to cover the cost of everything else, like the infusions, blood tests (there are many), and other tests necessary to determine your conditions before and after the trial. In my case the latter included CAT Scan and bone marrow analysis. If you have insurance they should cover all of that. In my case Medicare and my secondary Medigap insurance have covered everything.

[Pacificview in reply to Iupiter]

Thank you for that. I go on medicare origional, plan G supplement and D perscription plan FEB 1st. I asked because of the issue with at home cancer drug copays.

[Iupiter in reply to Pacificview]

If you are interested in taking part of the trial, and if I were you, I would start talking to my doctor right away about what could be done between now and February and that does not imply significant costs, so as to be ready to start the trial as soon as possible after Feb 1st. There is certain paperwork that needs to be completed. Also note that the doctor must have access to the trial. As far as I know, not just any doctor has access to it. Good luck!

[Pacificview in reply to Iupiter]

Well, there are some benefits to being old. It looks like origional medicare and plan G supplemental will take care of it for both of us...

[ttomo in reply to Pacificview]

Sorry I haven't answered more quickly! The trial drugs are free, but your own insurance has to cover the visits to the clinic, the blood tests, etc. Now I see that Lupiter has answered your question as well. Good luck with everything!!

[Iupiter in reply to ttomo]

Congratulations! I hope I can say the same thing at the end of next year.

[Iupiter in reply to ttomo]

Congratulations! I hope I can say the same thing at the end of next year.

[CAJan]

I am 3 months away from completion of CT #EA9161 (under 65, Phase III) with same RXs&amounts. Have have had no problems whatsoever in past 15 months. I was diagnosed 2016 w/CLL/SLL @age 61.

[Atds]

Hi Iupiter - I’m not on the trial but maybe this will help. I’m about to complete a year on O&V. My first drug was an O infusion and my liver values almost went off the chart on the first day. My hematologist gave me liquids and have me come in to test my liver values every day for the following 2 weeks. My values gradually became normal in three months - all is well now, but it was certainly frightening at the time.

[Iupiter in reply to Atds]

Thank you Atds! Did your doctor attribute the liver problem to the O? If so, why? In my case it was attributed to the I, not the O, as I explained in my first message. For me it was quite clear: I kept on getting O but not I and my liver returned to normal in three weeks. Had the problem been the O I wouldn't have gotten better. When you started did you get only O? How are you doing now? Did you have any other problems later? Thanks for sharing your experience.

[Atds in reply to Iupiter]

Hi Iupiter - my doctor attributed the liver problem to the O - he suspended it for a little while as my values corrected. It was at the beginning of treatment - I was on only O at the time and had taken all of the suggested tumor lysis preventions. He said he thought that nevertheless my liver was overwhelmed getting rid of the debris - he watched everything closely - each test was a little bit better - and eventually he was very happy with what the values became. All remains well. Hoping you have the same outcome.