← Back to Search

BTK Inhibitor

LOXO-305 for Chronic Lymphocytic Leukemia (BRUIN CLL-321 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 as defined by iwCLL 2018 criteria

Previously treated with a covalent BTK inhibitor

Must not have

Known or suspected Richter's transformation at any time preceding enrollment

Known or suspected history of central nervous system (CNS) involvement by CLL/SLL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 36 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition has transformed into a more aggressive form of cancer.

Select...

My CLL/SLL cancer may have spread to my brain or spinal cord.

Select...

I am currently experiencing liver problems due to medication.

Select...

I have an active, uncontrolled immune system disorder affecting my blood cells.

Select...

I have a serious heart condition.

Select...

I have active hepatitis B or C.

Select...

I do not have any ongoing serious infections.

Select...

I am HIV positive.

Select...

I have a severe digestive condition affecting nutrient absorption.

Select...

I have been treated with a reversible BTK inhibitor before.

Select...

I need blood thinners like warfarin for my condition.

Select...

I am currently taking medication that strongly affects liver enzymes.

Select...

I have not received a live vaccine in the last 28 days.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 36 months 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 LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)

Secondary study objectives

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 more