Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Summary
This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.
Arms & interventions
- DrugPirtobrutinib
Administered orally
- DrugIdelalisib
Administered orally
Outcome measures
Primary
Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)
Time frame: Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier
Secondary
Overall Survival
Time frame: Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months)
Eligibility criteria
Study locations (9)
Mitchell Cancer Institute
Mobile, Alabama, 36693
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, 85711
Cancer Specialists, LLC
Jacksonville, Florida, 32256
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433
Cayuga Cancer Center
Ithaca, New York, 14850
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
Oncology Hematology Care Inc
Cincinnati, Ohio, 45211
Texas Oncology - Paris
Fort Worth, Texas, 76104
US Oncology - Texas Oncology
Kyle, Texas, 78640