A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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
Loxo Oncology, Inc.
249 participants
Jan 3, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria9
- 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
Interventions
Administered Orally.
Locations(133)
View Full Details on ClinicalTrials.gov
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NCT06588478