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Bruton's Tyrosine Kinase (BTK) Inhibitor
Pirtobrutinib + VR for Chronic Lymphocytic Leukemia (BRUIN CLL-322 Trial)
Phase 3
Recruiting
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
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.
Who is the study for?
This trial is for people with CLL/SLL who need treatment and have already tried at least one therapy. They should be in fairly good health (ECOG 0-2), have a certain level of blood cells, and their kidneys must work well enough (creatinine clearance ≥30 mL/min). People can't join if they've had certain infections, HIV, hepatitis B or C, previous venetoclax treatment, allergies to the drugs used here, recent live vaccines or stem cell transplants.Check my eligibility
What is being tested?
The study tests Pirtobrutinib combined with Venetoclax and Rituximab against just Venetoclax and Rituximab in patients previously treated for CLL/SLL. The goal is to see which combination works better and is safer over up to five years.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as infections due to lowered white blood cells, bleeding issues from low platelets, anemia from low red blood cells; kidney problems; allergic reactions; fatigue; nausea; diarrhea.
BRUIN CLL-322 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My condition is CLL/SLL and needs treatment according to iwCLL 2018.
BRUIN CLL-322 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)
Secondary outcome measures
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS)
+4 moreBRUIN CLL-322 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (PVR)Experimental Treatment3 Interventions
Fixed duration pirtobrutinib in combination with venetoclax and rituximab
Group II: Arm B (VR)Active Control2 Interventions
Venetoclax with rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
2019
Completed Phase 3
~1950
Rituximab
1999
Completed Phase 4
~1880
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Who is running the clinical trial?
Loxo Oncology, Inc.Lead Sponsor
67 Previous Clinical Trials
9,589 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,624 Previous Clinical Trials
3,216,329 Total Patients Enrolled
Safi ShahdaStudy DirectorLoxo Oncology
1 Previous Clinical Trials
250 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (PVR)
- Group 2: Arm B (VR)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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