A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020
Disqualifiers
This is not applicable to this study
Trial design
Design model
Parallel
Treatments tested in this trial
Pirtobrutinib
DrugAdministered orally
Idelalisib
DrugAdministered orally
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Pirtobrutinib (Arm A)Experimental treatment 1 intervention
Group B: Idelalisib (Arm B)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 EarlierSecondary outcomes
1
Overall Survival
Overall survival is defined as the time from randomization in a randomized originator study, or from the first dose in a non-randomized originator study, until death from any cause
Time frame
Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months)Sponsors and contacts
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Source ClinicalTrials.gov