← Back to Search

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
Must not have
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Central nervous system (CNS) involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need blood thinners like warfarin for my condition.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have not received a live vaccine in the last 28 days.
Select...
I have been treated with venetoclax before.
Select...
I have not had a stem cell transplant or CAR-T therapy in the last 60 days.
Select...
I am HIV positive.
Select...
I am not taking medication that strongly affects liver enzymes.
Select...
I have a serious heart condition.
Select...
I am allergic to allopurinol and cannot take medication to lower uric acid.
Select...
My condition has transformed into a more aggressive form known as Richter's syndrome.
Select...
I have been treated with a reversible BTK inhibitor before.
Select...
I do not have any ongoing serious infections.
Select...
I have active hepatitis B or C.
Select...
I do not have uncontrolled ITP or AIHA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)
Secondary study objectives
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 more

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05176314
9%
Petechiae
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
200 mg Pirtobrutinib QD (Days 7-12)
20 mg Rosuvastatin (Day 1)
200 mg Pirtobrutinib QD (Days 14-17)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)

Awards & Highlights

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.

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
Rituximab
1999
Completed Phase 4
~2990
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
2019
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,460 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,672 Previous Clinical Trials
3,463,193 Total Patients Enrolled
Safi ShahdaStudy DirectorLoxo Oncology
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Pirtobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04965493 — Phase 3
Chronic Lymphocytic Leukemia Research Study Groups: Arm A (PVR), Arm B (VR)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Pirtobrutinib Highlights & Side Effects. Trial Name: NCT04965493 — Phase 3
Pirtobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04965493 — Phase 3
~178 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top