NCT06588478 · Loxo Oncology, Inc.
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
What this study is about
The main purpose of Part 1 of this study is to assess the effectiveness and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor.
View original scientific description
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions.
Interventions
DRUG
Pirtobrutinib
Administered Orally.
Primary outcome measures
Overall Response Rate
Time frame: Baseline up to 3 years
Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
- Part 1: Have received prior CLL/SLL treatment
- Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- Have received a covalent BTK inhibitor
- Part 2: Have received no prior treatment for CLL/SLL
- Part 1 - Known 17p deletion status (positive or negative)
- Part 2 - Must have 17p deletion (positive)
- Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- Capable of swallowing oral study medication.
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
Exclusion criteria
- Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
- Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
- Have known or suspected Richter's transformation
- Have known or suspected history of central nervous system involvement by
Where
- Chandler, Arizona
- Duarte, California
- Irvine, California
- Palo Alto, California
- Aurora, Colorado
- Miami, Florida
- Newnan, Georgia
- Waukee, Iowa
- Edgewood, Kentucky
- Bethesda, Maryland
- Boston, Massachusetts
- Gulfport, Mississippi
And 8 more locations — see the full list below.
Collaborators
Eli Lilly and Company
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations