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
Megadott ok: AstraZeneca has made the decision to cancel the trial.
Key facts
- Phase
- 2. fázis
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06839872
- Record updated
- 2025. június 5.
- Original description
To assess the efficacy and safety of pirtobrutinib in participants with CLL/SLL who have progressed on first-line treatment with acalabrutinib.Read full original descriptionShow less
BOSS: BTK Inhibitor Optimal Sequencing Study Phase II Open-label Single Arm Trial of Pirtobrutinib in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma After First-line Acalabrutinib Progression
To assess the efficacy and safety of pirtobrutinib in participants with CLL/SLL who have progressed on first-line treatment with acalabrutinib.
Inclusion: 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: 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 stroke or intracranial hemorrhage within 6 months before first dose of study drug; 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; History of bleeding diathesis (eg, hemophilia, von Willebrand disease); 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.