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A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
WithdrawnPhase 2
Sponsor: AstraZeneca
Conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Interventions: Pirtobrutinib, Acalabrutinib
To assess the efficacy and safety of pirtobrutinib in participants with CLL/SLL who have progressed on first-line treatment with acalabrutinib.
Eligibility overview
Sex: ALL
Age: 18 Years to 110 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Participant must be ≥ 18 at the time of signing the informed consent. * Participants must have received acalabrutinib monotherapy as first-line treatment for CLL/SLL, have progressed per the iwCLL Criteria (Hallek et al 2018) and be eligible for second-line treatment by the same criteria. * ECOG performance status of 0, 1, or 2. * Adequate organ and BM function. * Adequate coagulation, defined as aPTT or PTT and PT or INR not greater than 1.5 × ULN. * Participants have a clearly defined, documented and accessible start date of their first line acalabrutinib monotherapy for CLL/SLL. * Participants are eligible for the acalabrutinib retreatment phase only if they have progressed on pirtobrutinib monotherapy per iwCLL Criteria. Exclusion Criteria: * Major surgical procedure within 30 days before and not recovered adequately the first dose of study drug. * Participants who experienced a major bleeding event or Grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. * History of bleeding diathesis (eg, hemophilia, von Willebrand disease). * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug. * Significant cardiovascular disease. * History of PML. * Any active significant infection. * HIV positive * Active HBV or HCV infection. * Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression. * Active auto-immune cytopenia. * History of prior or current malignancy. * Requires or receiving therapeutic anticoagulation with warfarin or equivalent vitamin K antagonists. * Received a live virus vaccination within 28 days of first dose of study drug. * Requires treatment with a strong CYP3A inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited.