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

Sponsor: Loxo Oncology, Inc.

Sponsor score: 40

ClinicalTrials ID:NCT06588478

This clinical trial evaluates the efficacy and safety of three dose levels of Pirtobrutinib, administered orally, in participants with relapsed or refractory CLL/SLL. Eligible participants must have received 1-3 prior treatments, including a covalent BTK inhibitor, and meet iwCLL 2018 criteria. Participants should have an ECOG score of 0-2 and be able to swallow oral medication.

Patient Parameters

Program Overview

The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory 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 study is expected to last approximately 3 years.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
  • 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
  • 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 and 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 maligna 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

Locations

FACILITYZIPCITYSTATE
Ironwood Cancer & Research Centers85224ChandlerArizona
City of Hope National Medical Center91010DuarteCalifornia
City of Hope National Medical Center92618IrvineCalifornia
Palo Alto Medical Foundation Research Institute (PAMFRI)94304Palo AltoCalifornia
Stanford Cancer Center94304Palo AltoCalifornia
Rocky Mountain Cancer Center80012AuroraColorado
University of Miami Hospital and Clinics, Sylvester Cancer Center33136MiamiFlorida
Mission Cancer + Blood50309Des MoinesIowa
Saint Elizabeth Medical Center Edgewood41017EdgewoodKentucky
American Oncology Partners of Maryland, PA20817BethesdaMaryland

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