Are Body Cramps a Side Effect of CLL Treatment?

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Andrew Schorr:

So here's a question from Judy. She says, I'm not able to get an answer from my husband's oncologist regarding ibrutinib (Imbruvica) and severe body cramping.  Have there been any reports showing this is a possible side effect from ibrutinib?  

Dr. Sharman:

Absolutely, it is.  It is—well, absolutely possible, let's say that.  It actually is what I would say one of the most common side effects that I encounter as a limitation for ibrutinib. The medical term for it is arthralgias, which is sort of translates into joint pains.  Sometimes you'll also see actual cramps or spasms.  I've had patients' hands lock up when they're driving sometimes, which can be a little bit concerning.  

There is I think considerable question in the field.  There are differences amongst thought leaders on this as to whether—how to best manage it. 

There's some studies that suggest that lower dosages may—after a patient has been on ibrutinib for a length of time you may be able to get away with lower dosages.  Those pieces of clinical trial data are not as large and not as well validated, so I think it's still in the hypothesis?generating mode, but there's some data that suggest you could do it.  And if the choice was lower dose of ibrutinib or no dose of ibrutinib, I would probably go with a lower dose.  

The other potential solution now is acalabrutinib (Calquence), which is a second BTK inhibitor approved. It is approved by the FDA for mantle cell lymphoma.  However, a lot of the clinical trials are in chronic lymphocytic leukemia, and there have been studies that looked at patients who have limited tolerance of ibrutinib, and in many cases they were able to go on acalabrutinib without a recurrence of the same side effects.  

So that's another possibility. It is in the NCCN guidelines that for those patients who have intolerance of ibrutinib consider acalabrutinib.  So whether it's dose reduction or drug substitution, those are sometimes two ways that I use to get around that scenario.  

Andrew Schorr:

Okay.  Now, we should be clear that acalabrutinib is not yet approved for CLL.  Does it seem like that's forthcoming?  I mean, nobody can guess the FDA, but.  

Dr. Sharman:

Yeah.  So the clinical trial that will lead to approval, presumptive approval, was a head?to?head comparison against investigators' choice of bendamustine-rituximab (Bendeka-Rituxan) or idelalisib-rituximab (Zydelig-Rituxan), and that study is fully accrued and waiting for end points.  

And I think that the feeling would be that should be a positive test and that it would eventually get CLL approval.  Most of the studies have been done in CLL.  It's just the mantle cell indication came along more quickly. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.