Pirtobrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia
(BRUIN-CLL-314 Trial)

Recruiting in Palo Alto (17 mi)

+259 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Loxo Oncology, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.

Eligibility Criteria

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.

Inclusion 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 have been diagnosed with CLL/SLL and need treatment.

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Exclusion Criteria

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.

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Treatment Details

Interventions

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Pirtobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: PirtobrutinibExperimental Treatment1 Intervention

Administered orally.

Group II: IbrutinibActive Control1 Intervention

Administered orally.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: