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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
249
Administered Orally.
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope National Medical Center
Irvine, California, United States
RECRUITINGPalo Alto Medical Foundation Research Institute (PAMFRI)
Palo Alto, California, United States
Overall Response Rate
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.
Time frame: Baseline up to 3 years
Duration of Response
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.
Time frame: Baseline up to 3 years
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Stanford Cancer Center
Palo Alto, California, United States
RECRUITINGRocky Mountain Cancer Center
Aurora, Colorado, United States
RECRUITINGUniversity of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
RECRUITINGCity of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, United States
RECRUITINGMission Cancer + Blood
Waukee, Iowa, United States
RECRUITINGSaint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, United States
RECRUITING...and 121 more locations