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NCT05254743RECRUITINGIRB Ready

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

(BRUIN-CLL-314)

Sponsored by Loxo Oncology, Inc.

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of Part 1 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. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naΓ―ve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Who Can Participate

Inclusion Criteria

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate organ function
Platelets greater than or equal to β‰₯ 50 x 10⁹/liter (L) or β‰₯30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
Hemoglobin β‰₯8 grams/deciliter (g/dL) or β‰₯6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
Absolute neutrophil count β‰₯0.75 x 10⁹/L or β‰₯0.50 Γ— 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
Kidney function: Estimated creatinine clearance β‰₯30 milliliters per minute (mL/min)

Exclusion Criteria

Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia,

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

662 participants

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Gender

ALL

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Sponsor

Loxo Oncology, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Anaheim

California

Location available
View Anaheim location page
ACTIVE_NOT_RECRUITING

Cerritos

California

Location available
View Cerritos location page
RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
ACTIVE_NOT_RECRUITING

San Marcos

California

Location available
View San Marcos location page
ACTIVE_NOT_RECRUITING

Fort Myers

Florida

Location available
View Fort Myers location page
ACTIVE_NOT_RECRUITING

Saint Augustine

Florida

Location available
ACTIVE_NOT_RECRUITING

West Palm Beach

Florida

Location available
ACTIVE_NOT_RECRUITING

Baton Rouge

Louisiana

Location available
View Baton Rouge location page
ACTIVE_NOT_RECRUITING

New Orleans

Louisiana

Location available
View New Orleans location page

πŸ“ And 10 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

πŸ”’ Secure Β· πŸ₯ Expert Care

Looking for Chronic Lymphocytic Leukemia Treatment in Anaheim?

Join others in California exploring innovative treatment options through clinical research

Chronic Lymphocytic Leukemia Treatment Options in Anaheim, California

If you're searching for Chronic Lymphocytic Leukemia treatment in Anaheim, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Anaheim, Cerritos, Palo Alto and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Chronic Lymphocytic Leukemia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 662 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Chronic Lymphocytic Leukemia?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Chronic Lymphocytic Leukemia

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Chronic Lymphocytic Leukemia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05254743. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.