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A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06588478.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Florida
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura