Study identifier:D8220R00065
ClinicalTrials.gov identifier:NCT06839872
EudraCT identifier:N/A
CTIS identifier:N/A
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
Chronic Lymphocytic Leukemia
Phase 2
No
Pirtobrutinib, Acalabrutinib
All
0
Interventional
18 Years - 110 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
Eli Lilly and Company
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Pirtobrutinib and Acalabrutinib Participants will receive dose A of pirtobrutinib starting Cycle 1 Day 1 for up to 24 cycles or until disease progression, unacceptable toxicity, death, or withdrawal of consent. If they progress on pirtobrutinib, a subset will receive dose B of acalabrutinib starting Cycle 1 Day 1 for up to 12 cycles or until disease progression, death, intolerance, unacceptable toxicity, or withdrawal of consent. Those benefiting from treatment will enter the Disease Follow-up period, continuing with pirtobrutinib or acalabrutinib until disease progression, unacceptable toxicity, death, or withdrawal of consent. After 36 months from starting pirtobrutinib, participants can continue receiving treatment off-trial if beneficial, in consultation with their physician. | - |