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BTK Inhibitor
LOXO-305 for Chronic Lymphocytic Leukemia (BRUIN CLL-321 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
Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria
Previously treated with a covalent BTK inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 months
Awards & highlights
BRUIN CLL-321 Trial Summary
This trial is for people with CLL or SLL who have had treatment with a BTK inhibitor. They will compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab.
Who is the study for?
This trial is for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have had previous treatment including a BTK inhibitor. They should be in fairly good health, with specific blood counts and organ function levels meeting the study's criteria. People with certain heart diseases, active infections like hepatitis or HIV, recent live vaccinations, or known allergies to the drugs being tested cannot join.Check my eligibility
What is being tested?
The study compares LOXO-305 against two other treatments: Idelalisib plus Rituximab or Bendamustine plus Rituximab. Patients will receive one of these treatments based on random assignment and could participate for up to four years if their disease doesn't worsen.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, liver issues from drug interactions, and complications related to low blood cell counts such as increased infection risk. Each treatment has its own profile of potential side effects that participants will be monitored for.
BRUIN CLL-321 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...
I have been treated with a BTK inhibitor before.
Select...
I can perform daily activities with little to no assistance.
Select...
My kidneys are functioning well enough to clear waste.
BRUIN CLL-321 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 months
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 LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)
Secondary outcome measures
Time to worsening (TTW) of CLL/SLL related symptoms
Time to worsening (TTW) of physical function
To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)
+2 moreBRUIN CLL-321 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (LOXO-305)Experimental Treatment1 Intervention
Orally
Group II: Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR])Active Control3 Interventions
Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOXO-305
2021
Completed Phase 1
~60
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
3,201,267 Total Patients Enrolled
Safi Shahda, MDStudy DirectorLoxo Oncology
1 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active, uncontrolled immune system disorder affecting my blood cells.I have a serious heart condition.I can perform daily activities with little to no assistance.My kidneys are functioning well enough to clear waste.I have been diagnosed with CLL/SLL and need treatment.I have not received a live vaccine in the last 28 days.My hemoglobin level is at least 8 g/dL, or at least 6 g/dL if my bone marrow is affected.You have had a severe allergic reaction to rituximab in the past.My white blood cell count is within the required range for the trial.My CLL/SLL cancer may have spread to my brain or spinal cord.I need blood thinners like warfarin for my condition.I am currently taking medication that strongly affects liver enzymes.I have active hepatitis B or C.I do not have any ongoing serious infections.I am HIV positive.I have been treated with a reversible BTK inhibitor before.My condition has transformed into a more aggressive form of cancer.I am currently experiencing liver problems due to medication.I have not had a stem cell transplant or CAR-T therapy in the last 60 days.My platelet count meets the required level for the treatment I am considering.I have a severe digestive condition affecting nutrient absorption.I have been treated with a BTK inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (LOXO-305)
- Group 2: Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [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.
How many individuals are a part of this clinical research project?
"The study's sponsor, Eli Lilly and Company, needs to enroll 250 eligible patients at different trial sites, including Northwest Medical Specialties, PLLC in Tacoma, Washington and Community Health Network in Indianapolis, Indiana."
Answered by AI
What is the FDA's opinion of LOXO-305?
"LOXO-305's safety is rated at a 3 because this is a phase 3 trial, which suggests that there is efficacy data as well as multiple rounds of safety data."
Answered by AI
What other studies have looked at the effectiveness of LOXO-305?
"LOXO-305 was first studied in 1993 at National Institutes of Health Clinical Center. So far, 889 clinical trials have completed and 471 are ongoing. Many of these live trials are taking place in Tacoma, Washington."
Answered by AI
What is LOXO-305 used to treat most often?
"DLBCL is most effectively treated with LOXO-305, but this medication can also assist patients battling hodgkin disease, chronic lymphocytic leukemia, and other b-cell lymphomas."
Answered by AI
Are researchers still recruiting people for this experiment?
"This trial, which was first posted on clinicaltrials.gov on 3/9/2021, is actively seeking patients. The last edit to the posting was on 10/13/2022."
Answered by AI
Is this clinical trial limited to only a few facilities in Canada?
"The 67 clinical trial sites for this medical study are located across the states of Washington, Indiana, and Texas. The primary locations for this study are Northwest Medical Specialties, PLLC in Tacoma, Washington, Community Health Network in Indianapolis, Indiana, and Texas Oncology - San Antonio Medical Center in San Antonio, Texas."
Answered by AI
Who else is applying?
What site did they apply to?
Rush University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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