Home › Trials › NCT06588478

Evaluating Pirtobrutinib for patients with relapsed or refractory CLL/SLL

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Phase 2 Interventional Eli Lilly and Company · NCT06588478

This study is testing a new medication called Pirtobrutinib to see if it helps people with relapsed or hard-to-treat chronic lymphocytic leukemia or small lymphocytic lymphoma feel better after they’ve already tried other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment249 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsPirtobrutinib
Locations132 sites (Chandler, Arizona and 131 other locations)
Trial IDNCT06588478 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy and safety of Pirtobrutinib at three different dose levels in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants must have received 1 to 3 prior lines of treatment, including a covalent Bruton tyrosine kinase (BTK) inhibitor. The study aims to determine how well this medication works over approximately three years.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of CLL/SLL who have received prior treatment and require therapy.

Not a fit: Patients with a history of severe bleeding due to BTK inhibitors or those with central nervous system involvement by CLL/SLL may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat CLL/SLL.

How similar studies have performed: Other studies have shown promise with similar approaches using BTK inhibitors, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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

Where this trial is running

Chandler, Arizona and 131 other locations

+82 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.