Study on the Effectiveness and Safety of Pirtobrutinib for Patients with Relapsed or Hard-to-Treat Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: Loxo Oncology, Inc.

Sponsor score: 40

ClinicalTrials ID:NCT06588478

This clinical trial is testing the effectiveness and safety of different doses of Pirtobrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or is difficult to treat after previous therapies. The study will last about 3 years.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well Pirtobrutinib works and how safe it is for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or is not responding to treatment. Participants will have previously received 1 to 3 different treatments, including a specific type of medication called a covalent BTK inhibitor. The study will explore three different dose levels of Pirtobrutinib over a period of approximately 3 years.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Have received previous treatment for CLL/SLL.
  • Have had 1 to 3 prior treatments for CLL/SLL.
  • Have been treated with a covalent BTK inhibitor.
  • Need treatment according to specific medical guidelines.
  • Be able to swallow pills.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have been treated with a BTK degrader and a noncovalent BTK inhibitor before.
  • Have experienced severe bleeding (Grade 3 or higher) due to a BTK inhibitor.
  • Have known or suspected transformation to a more aggressive form of lymphoma (Richter's transformation).
  • Have known or suspected involvement of the central nervous system by CLL/SLL.
  • Have had another type of cancer within the last 3 years, except for certain cases like nonmelanoma skin cancer, cervical carcinoma in situ, localized prostate cancer under active surveillance, or localized breast cancer with no active disease for more than 3 years.

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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