Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06588478

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

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. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pirtobrutinib

Drug

Administered Orally.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of Response

    Time frame: Baseline up to 3 years

    Duration of response is defined as the time from the date of the first documented CR, CRi, nPR, or PR to disease progression (per iwCLL 2018) or death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Loxo Oncology, Inc.

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.