Time to decide about leaving the initial NON TIME LIMITED Captivate trial because of potential toxicity

[I282much]

Hi all,

My husband is in the initial 164 trial group of Non Time limited Captivate Trial. The trial design was Venetoclax ramp up and then ibrutinib until MRD. When MRD was achieved, a blind was set up for placebo vs Ibrutinib indefinitely, or until progression/toxicity.

Since MRD, we have settled into life again. However, the specialist feels that building side effects that he is experiencing are due to Ibrutinib. He suggested that we consider going off trial because TIME LIMITED THERAPY is becoming standard.

The Dr. and research assistant seem to think that there will always be another trial or drug to help if he takes an ibrutinib vacation and that he should take this time to have less pain to enjoy marathon running again.

During our “rest period” , I have done less research than I did eight years ago and am now faced with the potential concerns about financial toxicity and progression if he goes off of the trial. We have felt so blessed to have MRD and the safety net of free back up Venetoclax . We now have a lot to think about and research again.

Does anyone else have any similar experiences? I would love to hear how would or have processed this.

It’s just such a scary thought to start over again!

I apologize for the extended post, but, you guys always seem to have wonderful feedback!

L

[ornstin]

Hi

I am being treated but not taking the treatment your husband is.

I am assuming you mean your husband has reached UMRD (Undetectable Minimum Residual Disease), with a Complete Response, otherwise (I'm sorry to say) I don't fully understand the reasoning.

If I was his in position, and based on the above assumption, I would be thinking of following the advice your specialist has given but would also probably seek a second opinion as well if one was available. I would be concerned about toxicities and also development of resistance to the medications-increasingly likely as time goes on. It also seems relevant that those on the time-limited arm of the Captivate trial have done very well so far-but it is still early days, so there is an element of uncertainty in all this.

I decided to reply due to lack of responses. Best wishes, Antony