Promising trial: This sounds promising but must... - CLL Support

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Promising trial

Bornagain514 profile image
7 Replies

This sounds promising but must admit much of it is over my head. Happy reading!

cllsociety.org/2024/08/firs...

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Bornagain514 profile image
Bornagain514
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7 Replies
AussieNeil profile image
AussieNeilPartnerAdministrator

The Bottom Line:

Venetoclax–obinutuzumab and ibrutinib-venetoclax-obinutuzumab produce more prolonged remissions than chemoimmunotherapy and venetoclax-rituximab in patients with CLL.

Bornagain514 profile image
Bornagain514 in reply to AussieNeil

Thank you for the clarification. I appreciate it. I'm new to this world and trying to wrap my head around the meds, symptoms, etc...Blessings to all who contribute to this forum.

Lil0ppie profile image
Lil0ppie in reply to AussieNeil

Could you explain what is meant by remission here? I think of the term to mean a period marked by the disappearance of signs or symptoms of disease, but is it right to refer to remission when you have to remain on medication to keep a disease at bay?

AussieNeil profile image
AussieNeilPartnerAdministrator in reply to Lil0ppie

Time to next treatment and progression free survival are better defined than remission. From the iwCLL 2018 guidelines, with my emphasis in regard to your question regarding "when you have to remain on medication to keep a disease at bay";

5.6. Time to next treatment, progression-free survival, event-free survival, and overall survival

Progression-free survival is defined as the interval between the first treatment day (in phase 3 trials: day of randomization for intent-to-treat analysis) to the first sign of disease progression or death from any cause. Event-free survival is defined as the interval between the first treatment day (in phase 3 trials: day of randomization for intent-to-treat analysis) to the first sign of disease progression or start of a new treatment or withdrawal from the trial because of toxicity or death (whichever occurs first).

Overall survival is defined as the interval between the first treatment day (in phase 3 trials: day of randomization for intent-to-treat analysis) to death. Time to next treatment is defined as interval between the first treatment day until the patient starts an alternative therapy for progressive CLL.

Note that the response duration may be assessed during therapy for continuous treatment, in particular with oral agents, as well as after the end of treatment, in particular with chemo(immuno)therapy. Study protocols should provide detailed specifications of the planned time points for the assessment of the treatment response under continuous therapy. Response durations <6 months are not considered clinically relevant (see refractory disease, section 5.8).

Neil

Lil0ppie profile image
Lil0ppie in reply to AussieNeil

Thanks!

Shepherd777 profile image
Shepherd777

My wife was not on a trial, but did Imbruvica for about 3 months. She stopped Imbruvica and a month later went on Venetoclax for about a year and then took a vacation from all treatment. She remained in clinical remission for a little over 3 and a half years.

Please note her treatment was sequential and not in combination at the same time.

Skyshark profile image
Skyshark

The CLL13 trial didn't find a significant difference between Venetoclax + Obinutuzumab and Venetoclax + Ibrutinib + Obinutuzumab. The addition of Ibrutinib increases the cost by about 75%.

CLL13 didn't include those that are "hard to treat" with TP53 aberrations.

There are other triple drug trials in progress. CLL17 is a major trial of 2 and 3 drug combinations.

Each additional drug comes with it own set of side effects and increases the possibility of early discontinuation.

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