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Pirtobrutinib for Relapsed or Untreated CLL/SLL

This study is testing a drug called Pirtobrutinib for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Pirtobrutinib works by targeting a specific protein called tyrosine kinase. The study has two parts. Part 1 is for those who have already received 1 to 3 prior treatments, including a BTK inhibitor. Part 2 is for those who have not had any prior treatment for CLL/SLL and have a specific genetic change called a 17p deletion. Researchers want to see how well Pirtobrutinib works (Overall Response Rate) and if it is safe. The study plans to enroll 249 participants aged 18 and older.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 249 participants.
What's involved
Participation in Part 1 is expected to last about 3 years, and in Part 2, up to 2 years. The drug Pirtobrutinib is given orally.
Compensation
Not stated in the trial record.
Follow-up
The Overall Response Rate will be measured from the start of the study up to 3 years.

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NCT06588478

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Loxo Oncology, Inc.
~249 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Pirtobrutinib

At a glance

Recruiting sites
131 of 131 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over Baseline up to 3 years

Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaLoss of Chromosome 1p

Where it's being run

131 sites across 34 states
Spain14
Australia10
Italy10
Belgium9
Turkey (Türkiye)9
United Kingdom9
France6
Germany6

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 CLL/SLL
Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
nonmelanoma skin cancer or lentigo malignant melanoma
cervical carcinoma in situ
localized prostate cancer undergoing active surveillance, and
localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

What this trial measures

  • Overall Response RateBaseline 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.