Your session is about to expire
← Back to Search
Alkylating agent
Pirtobrutinib vs BR for Leukemia (BRUIN CLL-313 Trial)
Phase 3
Waitlist Available
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
Kidney function: Estimated creatinine clearance ≥40 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
BRUIN CLL-313 Trial Summary
This trial will compare the effectiveness and safety of a new drug, pirtobrutinib, to a standard drug, BR, in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Who is the study for?
This trial is for untreated patients with CLL/SLL who need therapy. They must have a certain level of blood cells and organ function, no severe allergies to the drugs being tested, no active hepatitis B/C or HIV, and not be on other cancer treatments or recent live vaccines.Check my eligibility
What is being tested?
The study compares Pirtobrutinib (LOXO-305) against Bendamustine plus Rituximab in treating CLL/SLL. Participants will receive one of these treatments randomly and their health outcomes will be monitored for up to five years.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, potential bone marrow suppression leading to low blood cell counts, risk of infections due to weakened immune system, and various organ-specific inflammations.
BRUIN CLL-313 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL/SLL and need treatment.
Select...
My kidneys work well enough (creatinine clearance ≥40 mL/min).
Select...
I can take care of myself and am up and about more than half of my waking hours.
BRUIN CLL-313 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 (Arm A) compared to bendamustine 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 effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
+4 moreBRUIN CLL-313 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (Pirtobrutinib)Experimental Treatment1 Intervention
Pirtobrutinib administered orally
Group II: Arm B (BR)Active Control2 Interventions
Bendamustine plus rituximab administered intravenously (IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Find a Location
Who is running the clinical trial?
Loxo Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
9,619 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,310 Total Patients Enrolled
Safi ShahdaStudy DirectorLoxo Oncology
1 Previous Clinical Trials
600 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a 17p deletion.I have active hepatitis B or C.I do not have any ongoing serious infections.I have not received a live vaccine in the last 28 days.My cancer has spread to my brain or spinal cord.I have been diagnosed with CLL/SLL and need treatment.I need blood thinners like warfarin for my condition.My organs are working well.I am HIV positive.My condition has transformed into a more aggressive form known as Richter's syndrome.I have received treatment for CLL/SLL before.I am not using any experimental drugs or cancer treatments, except for hormone therapy.I have a serious heart condition.I do not have an active, uncontrolled autoimmune blood disorder.My kidneys work well enough (creatinine clearance ≥40 mL/min).I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Pirtobrutinib)
- Group 2: Arm B (BR)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other examples of Pirtobrutinib being studied in a lab setting?
"Pirtobrutinib was first researched in 1993 at National Institutes of Health Clinical Center. So far, 876 completed studies have been conducted. There are 461 clinical trials still recruiting patients, many of which are based in Tamarac, Florida."
Answered by AI
What are Pirtobrutinib's most common applications in medical settings?
"Pirtobrutinib is frequently utilized to treat patients with diffuse large b-cell lymphoma. However, it can also be an effective medication for hodgkin disease, b-cell lymphomas, and polyangium."
Answered by AI
Are there unfilled vacancies in this clinical trial for new enrollees?
"The clinical trial is currently active and is looking for 250 patients from 7 different sites, as stated on clinicaltrials.gov. This particular trial was originally posted on September 23rd, 2021 and was updated on October 12th, 2022."
Answered by AI
Does Pirtobrutinib carry a high risk for patients?
"Pirtobrutinib's safety is estimated to be a 3. This ranking comes from the fact that Pirtobrutinib is in Phase 3 clinical trials."
Answered by AI
How many different facilities are handling this research?
"There are 7 medical research facilities around the country currently conducting this study. Some notable locations include Oncology-Hematology Associates of West Broward in Tamarac, California Research Institute in Los Angeles, and Clinical Research Alliance, Inc. in Westbury."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger