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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 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.

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

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

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 more

BRUIN 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

~1990

Rituximab

1999

Completed Phase 4

~1880

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor

67 Previous Clinical Trials

9,489 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,624 Previous Clinical Trials

3,216,197 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

2021. "A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965493.

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