Debulking Eliminates Need for Hospitalization Prior to Initiating Venetoclax Therapy in untreated CLL pts

[Jm954]

This is a report of Phase 3 study NCT03406156.

Due to the rapid induction of cell death caused by the targeted activity of venetoclax, some patients require inpatient monitoring for tumor lysis syndrome (TLS) at initiation of therapy. In the recent CLL14 study, 64% and 22% of venetoclax-treated patients were medium and high risk for TLS, respectively.

This study used disease re-staging every two cycles to explore the efficacy of using of obinutuzumab, with or without bendamustine prior to initiation of venetoclax, to reduce tumor burden and thus eliminate the need for hospitalizations, as well as reduce the risk for TLS at the initiation of venetoclax therapy.

Two cycles of obinutuzumab prior to initiation of venetoclax was an effective debulking strategy for patients with ALC >25 × 109 /L and lymph nodes <5 cm, with over 98% success rate; the addition of bendamustine increased effective debulking for patients with nodes 5–10 cm. Patients with nodes >5 cm treated with obinutuzumab or >10 cm treated with obinutuzumab plus bendamustine may need >2 cycles to achieve low tumor burden.

Debulking via obinutuzumab, with or without bendamustine, may allow more patients to be administered venetoclax in the outpatient setting, eliminating the need for hospitalization during venetoclax initiation.

Details here: ash.confex.com/ash/2019/web...

Jackie

[Yidarmy69]

Hi I’m on a trial on Acalabrutinib do you know if this has a similar effect as I’m going to start Venetoclax in January cheers

[Jm954 Administrator in reply to Yidarmy69]

Hard to know without specific details of your tumour load - size of LNs and lymph count. Ibrutinib patients in the FLAIR trial moving onto Venetoclax were still at risk of TLS some weeks/months later. Your doctor will certainly make the assessment much nearer the time of the start of Venetoclax and err on the side of caution I'm sure.

Jackie

[Yidarmy69 in reply to Jm954]

Thank you

[Rafe]

Great news for those heading towards the ramp-up. The hospital stays are tedious, but I can appreciate their necessity.

[giuliano]

DEAR FRIEND

MY EXPERIENCE HAS BEEN WITH LEUKERAN + GAZYBA (OBINUTUZUMABE)

6 MONTHS OF TRATMENT

FIRST TREATMENT (ABOUT 1 AND A HALF YEARS AGO) WAS DIFICULT BECAUSE OF BODY REACTION.

THANKS GOD IT HAS BEEN EXCELLENT SO FAR NO PROBLEMS

ONLY RECOMENDATION IS TO GET BODY PREPARED BEFORE FIRST APLICATION

( I HAD CORTICOIDS )

GOOD LUCK AND SORRY TO WRITE IN CAPITAL LETTERS

[giuliano]

SORRY IT IS NOT 11 YEARS ITS 1 YEAR AND A HALF

[Jm954 Administrator in reply to giuliano]

WOW! That's great guiliano

Jackie

[GrapeGrower1]

Thanks for keeping us up to date on this. I'm unmutated so Obinutuzumab + Venetoclax will be my preference. My counts have been unchanged for about 2.5 years now but my lymph nodes have cycled pretty significantly. I do take heart in Neil's observation: lymph nodes come and go. I'm back at Froedtert in Milwaukee next week for my checkup. I have a full time engineering job and a business that is growing fast. No time for hospitals:-). Although my doctor assured me I'd have to slow down when I start treatment.

[Jm954 Administrator in reply to GrapeGrower1]

All the best for your future treatment, whenever it comes. Ob+Ven would be a good one

Jackie

[Smakwater]

Worked for me, literally.

After each infusion there was a one hour observation period, and then I was released on my own. My CBC counts came back in range after the 3rd obinutuzumab infusion, and I had no adverse blood count fluctuation during the ramp up.

I experienced some creatinine fluctuation due to inadequate hydration, but with appropriate water intake I am still able to manage that issue.

At month seven I developed mild neutropenia dropping below 1.0 on the last obinutuzumab/venclexta combination, however, since then I have been above 1.0 with venclexta alone.

I have not experienced any fever producing infections, nor have I been sick during my participation.

In a nut shell - Debulking with obinutuzumab shows effective lowering TLS risk with venclexta. Fortunately I fit the publication profile.

Not totally a walk in the park though, yet I will spare you the aggravation graphics and drama for now.

Three weeks of venclexta left and we monitor durability.

Hoping for a long remission, or maybe even no reoccurrence.

Then the same for all,

JM

[Jm954 Administrator in reply to Smakwater]

I'm pleased to hear that it worked for you. Fingers crossed for a very long remission (dare we hope for cure?)

Jackie