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Bruton's Tyrosine Kinase (BTK) Inhibitor
Pirtobrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia (BRUIN-CLL-314 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the date of the first documented response of cr, cri, npr or pr to the earlier of documentation of definitive pd (per iwcll 2018 criteria) or death from any cause (approximately 2 years)
Awards & highlights
BRUIN-CLL-314 Trial Summary
This trial is testing a new drug to see if it is better than the standard treatment for people with CLL/SLL. It will last up to 6 years.
Who is the study for?
This trial is for people with CLL/SLL who may need treatment. They should have a certain level of platelets, hemoglobin, and neutrophils; adequate kidney function; and be in fair to good physical condition (ECOG 0-2). It's not for those with uncontrolled autoimmune issues, history of certain lymphomas or leukemia transformations, significant other diseases, active infections like hepatitis B/C or HIV, ongoing inflammatory bowel disease, prior BTK inhibitor use, on strong blood thinners or immune-suppressing drugs.Check my eligibility
What is being tested?
The study compares Pirtobrutinib (LOXO-305) against Ibrutinib in treating CLL/SLL. Participants will either receive the new drug Pirtobrutinib or the established drug Ibrutinib to see which one works better and is safer. The trial could involve participants for up to six years.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as allergies or anaphylaxis especially if there's known hypersensitivity to components of either drug. Other risks might involve changes in blood counts leading to increased infection risk and potential impacts on organ functions.
BRUIN-CLL-314 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the date of the first documented response of cr, cri, npr or pr to the earlier of documentation of definitive pd (per iwcll 2018 criteria) or death from any cause (approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the date of the first documented response of cr, cri, npr or pr to the earlier of documentation of definitive pd (per iwcll 2018 criteria) or death from any cause (approximately 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Event-Free Survival (EFS)
Overall Survival (OS)
+3 moreBRUIN-CLL-314 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PirtobrutinibExperimental Treatment1 Intervention
Administered orally.
Group II: IbrutinibActive Control1 Intervention
Administered orally.
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
9,219 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,200,867 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,061 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My platelet count is at least 50, or 30 if my bone marrow is affected.My white blood cell count is within the required range.I am not using any experimental drugs or cancer treatments, except for hormone therapy.I do not have any ongoing serious infections.I have a condition that affects how my body absorbs medicine taken by mouth.I have an active inflammatory bowel disease.I have not received a live vaccine in the last 28 days.I have been diagnosed with CLL/SLL and need treatment.My heart's pumping ability is strong and I don't have irregular heartbeats.My cancer has spread to my brain or spinal cord.I can take care of myself and am up and about more than half of my waking hours.My organs are working well.I do not have an active, uncontrolled autoimmune blood disorder.My condition has transformed into a more aggressive form of cancer.I have a significant history of kidney, nerve, mental health, hormone, metabolism, or immune system diseases.My hemoglobin level is at least 8 g/dL, or at least 6 g/dL if my bone marrow is affected.I need blood thinners like warfarin for my condition.I am not on long-term strong CYP3A inhibitors, or I can stop them before starting the study drug.I am taking 20 mg or more of prednisone daily or an equivalent dose of another steroid.My kidneys work well enough (creatinine clearance ≥30 mL/min).I am HIV positive.I have previously been treated with a BTK inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Pirtobrutinib
- Group 2: Ibrutinib
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 current openings for volunteers in this trial?
"Yes, this information can be found on clinicaltrials.gov. The trial was posted on July 22nd, 2022 and was updated October 11th, 2022."
Answered by AI
Are there long-term negative effects to taking Pirtobrutinib?
"Pirtobrutinib has received a safety score of 3."
Answered by AI
How many participants are taking part in this research?
"That is correct. The information available on clinicaltrials.gov seems to show that this study is still looking for patients. The trial was first posted on July 22, 2022 and was last edited on October 11, 2022. They are looking for 650 patients across 10 different locations."
Answered by AI
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