New Clinical Trail EA9161 with great results!

[Riven8]

Hello folks. I have been on the site for a while and I have placed a couple of post but more an observer. I have something to share that I am pretty excited about. I started on a new Clinical Trial on December 19th. The clinical trial information can be found at ClinicalTrials.gov: and the study number is EA9161. “A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)”.

I had a new CT scan and bone marrow biopsy the week before I started treatment. The morning of the infusion they drew 20 vials of my blood. I was randomly selected for Arm A. My first infusion of Obinutuzumab was on the 19th of December. The infusion process took a full day. A few hours into the infusion I started getting hot and clammy. The infusion nurse checked my temperature and it showed normal but I was feeling worst. When she checked my blood pressure it was really low. She called for some help and started giving me some additional fluids and they put me on oxygen as a precaution. Within a half an hour I was back to feeling normal. They had stopped the infusion when the reaction happened and then restarted it and there were no other issues. My second infusion was the next day with a stronger dose but started off at a lower rate and increased over a few hours with no issues. They gave me additional medicines to counteract the reaction. I have now had four infusions without issues.

The result of my blood work was unbelievable. My blood the day of the infusion were as follows:

LYMPHOCYTES MANUAL COUNT 109.16 x1000/mcL (149 August 2019)

LYMPHOCYTES % MANUAL COUNT 93.7

WBC'S AUTO 116.5 x1000/mcL

PLATELETS, AUTOMATED COUNT 120 x1000/mcL

One week later:

LYMPHOCYTES MANUAL COUNT 7.10 x1000/mcL

LYMPHOCYTES % MANUAL COUNT 67.0

WBC'S AUTO 10.6 x1000/mcL

PLATELETS, AUTOMATED COUNT 71 x1000/mcL (Jan 1st 155 x1000/mcL)

I have had no side effects so far. With Arm A I have also been taking Ibrutinib since the first day (3 capsules). The benefits of Arm A is the hope that after 19 cycles (28 days per cycle) I will no longer need to take the drugs. I am 60 years old and live in Oregon, USA!

[Panz]

This is terrific news!!! Thanks for sharing it with us. Please keep us posted. I am excited for you!!!

Panz 🙏💕☘️😍

[Riven8 in reply to Panz]

Thanks

[Pinhead1]

So excited for you being in the clinical trial. My husband has been in it since May of 2019. All of his blood work shows normal numbers. He gets off of the trial in July of 2020. Which hospital in Oregon is doing the trial?

[Riven8 in reply to Pinhead1]

My medical insurance is provided in southern CA so I drive down there for treatments and appointments. I go to Kaiser Permanente.

[Pinhead1 in reply to Riven8]

Is your Dr. Thomas Kipps? Love him

[Riven8 in reply to Pinhead1]

No. My Dr. is Dr. Thu-Tam Thi Huynh she is very knowledgeable and has actually been involved in other CLL clinical trials before.

[bertie260 in reply to Pinhead1]

How was your husbands quality of life during the trial. Can he work, go out etc. ? Thanks

[Pinhead1 in reply to bertie260]

In the first 3 months, it was knocking out his cancer. Every month his blood work looked better and better. He is working full time, but he doesn't have the energy he use to have. He had a virus over Christmas and he is now feeling much better. We also went on a vegetarian, no milk and no sugar diet.

[bertie260 in reply to Pinhead1]

Thank you.

[edelweiss]

Congratulations Riven8 and thanks for letting us know of your excellent progress . Keep us updated. We all learn together! Edelweiss

[Riven8 in reply to edelweiss]

Thanks, I will.

[MGirl-Aust]

Hi Riven8, great to hear you’ve had such a good response so quickly 😊. Twenty vials of blood on one day, my goodness! Stay well, and do keep us posted on how you go...

[Riven8 in reply to MGirl-Aust]

I will. Yes that amount of blood drawn was my record.

[Smac29]

So happy for you and thanks for sharing! Looking forward to your next post.

Sheryl

Living in California 😃

[Riven8 in reply to Smac29]

Thanks

[caven]

This head-to-head open-label trial of I+O, with and without V is a MAJOR step in the direction of better understanding which COMBINATION of novel agents is the more effective.

It is no surprise that 700+ locations across USA have the capacity to monitor the 720 pts in the study (still recruiting!). The study began in January of '19 and will end in October '25. It's likely that ASH 2023 will be the first to post preliminary results.

Thanks everyone who is participating. It really feels as if this is the holy-grail for testing the ideal combination of medicines for defanging CLL.

Caven

[Riven8 in reply to caven]

I hope so!

[Justasheet1]

Riven,

That’s a great trial. You have a long way to go on it. The results you say are from the obinutuzamab.

I had an awful reaction during the first dose too but my WBC plummeted from 266 to 6 in one week. I wish it would always continue to do that but that’s not how things work.

Congrats on your great news and keep us posted.

Jeff

[Riven8 in reply to Justasheet1]

It is from the infusion and Ibrutinib. I started on Ibrutinib the same day as the infusion. So far I feel very lucky with no side affects.

[CLLCalifornia-USA]

Thanks so much for sharing your results and for participating in a trial. I’m excited to hear more as you continue with the trial. You give us encouragement that a cure is in the near future. Prayers for continued success. 🙏 Sally

[Riven8 in reply to CLLCalifornia-USA]

Thanks for your response

[Mystic75]

Great news, Riven8! Thank you so much for sharing!

All the best for continued success and please keep us updated.

D.

[Riven8 in reply to Mystic75]

Thanks!

[casanova]

Hope all continues to go well on the trial.

MaureenUK

[Riven8 in reply to casanova]

Thanks!

[Mldeterm]

My husband is on his 9th cycle of the same arm of the same trial and is doing great! No side effects and feeling fantastic. Hoping for a MRD- result in cycle 19.

Mindy

[Riven8 in reply to Mldeterm]

That sounds great. I hope the best for him. Thanks!

[AussieNeil Partner Administrator]

This is a very similar and exciting combination of the trial I am on, where Acalabrutinib is used instead of the first generation BTK inhibitor Ibrutinib. I predict these combinations will be the future of CLL short term non-chemo treatments for many of us.

healthunlocked.com/cllsuppo...

From what I have heard about my trial participants, adding the Obinutuzumab/Gazyva may enable those struggling with neutropenia to achieve enough bone marrow clearance to achieve the Venetoclax ramp up. I will find out in a month's time if that's the case with me.

Please keep us informed on your progress on this very interesting clinical trial.

Neil

[Riven8 in reply to AussieNeil]

Sounds good. I hope all goes well for you in a month!