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)
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!
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Riven8
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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?
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.
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...
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.
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.
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
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.
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.
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.
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