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Bruton's Tyrosine Kinase (BTK) Inhibitor

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

Be older than 18 years old

Must not have

Active uncontrolled systemic bacterial, viral, or fungal infection

Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments

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

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

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

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I do not have any ongoing serious infections.

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I have a condition that affects how my body absorbs medicine taken by mouth.

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I have an active inflammatory bowel disease.

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My heart's pumping ability is strong and I don't have irregular heartbeats.

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My cancer has spread to my brain or spinal cord.

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I do not have an active, uncontrolled autoimmune blood disorder.

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

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I am HIV positive.

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I have previously been treated with a BTK inhibitor.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Duration of Response (DOR)

Event-Free Survival (EFS)

Overall Survival (OS)

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