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Pirtobrutinib + VR for Chronic Lymphocytic Leukemia (BRUIN CLL-322 Trial)
BRUIN CLL-322 Trial Summary
This trial is comparing the efficacy and safety of a new drug, pirtobruitinib, to the standard treatment, VR, in patients with CLL/SLL.
BRUIN CLL-322 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRUIN CLL-322 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BRUIN CLL-322 Trial Design
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Who is running the clinical trial?
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- I have been treated with a specific cancer medication before.I need blood thinners like warfarin for my condition.My cancer has spread to my brain or spinal cord.I have not received a live vaccine in the last 28 days.I have been treated with venetoclax before.I have not had a stem cell transplant or CAR-T therapy in the last 60 days.I am HIV positive.I am not taking medication that strongly affects liver enzymes.I have a serious heart condition.My organs are working well.I am allergic to allopurinol and cannot take medication to lower uric acid.My condition has transformed into a more aggressive form known as Richter's syndrome.I have been treated with a reversible BTK inhibitor before.I do not have any ongoing serious infections.I have active hepatitis B or C.I do not have uncontrolled ITP or AIHA.I can take care of myself and am up and about more than half of my waking hours.My condition is CLL/SLL and needs treatment according to iwCLL 2018.I've had treatment including a BTK inhibitor and my blood counts meet specific levels.
- Group 1: Arm A (PVR)
- Group 2: Arm B (VR)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the primary indications for Pirtobrutinib?
"The FDA-approved use for pirtobrutinib is to treat diffuse large b-cell lymphoma (DLBCL). However, medical professionals have also found it effective in treating other conditions like b-cell lymphomas, polyangiitis, and pemphigus vulgaris."
Are there any documented cases of Pirtobrutinib being harmful to patients?
"Pirtobrutinib's Phase 3 status and the clinical data supporting its efficacy and safety justifies a score of 3."
What is the upper limit for subjects in this clinical trial?
"That is correct. The listing on clinicaltrials.gov does show that the trial is recruiting patients as we speak. This particular study was first posted on September 20th, 2021 and has since been updated on November 11th, 2022. In total, 41 different sites are participating in this research and they are looking to enroll 600 individuals in total."
Can you provide more context on Pirtobrutinib research?
"There are currently 617 ongoing clinical trials for Pirtobrutinib, 118 of which have reached Phase 3. Although many of these studies began in Edmonton, Alberta, there are 20845 total locations running Pirtobrutinib trials."
Could you tell me how many study sites are currently active?
"There are a total of 41 locations at which this clinical trial is taking place. Some notable examples include Memorial Sloan Kettering Cancer Center in New york, Pikeville Medical Center, Inc. in Pikeville, and Sunnybrook Health Sciences Centre in Toronto."
Is it possible to enroll in this experiment at present?
"That is correct. The listings on clinicaltrials.gov show that this study, which was first announced on September 20th, 2021, is still recruiting patients. They are looking for 600 individuals total at 41 different sites."
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