A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Leucemia mieloide aguda, Leucemia mieloide crónica, Linfoma, Leucemia
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Sergio Ramos
FECHA DE APERTURA
Noviembre, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria.
Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
CRITERIOS DE EXCLUSIÓN
Known prolymphocytic leukemia or history of, or currently suspected, Richters transformation.
Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL.
History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug.
Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or non covalent BTKi (ncBTKi). Patients who discontinue cBTKi due solely to toxicity are not eligible
History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL.
History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug.
Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or non covalent BTKi (ncBTKi). Patients who discontinue cBTKi due solely to toxicity are not eligible
History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
DESCRIPCIÓN
To evaluate the efficacy of BGB-16673 compared to pirtobrutinib as measured by progression-free survival (PFS) determined by independent review committee (IRC)
PALABRAS CLAVE
chronic leukemia, chronic lymphocytic leukemia (cll), leukemia, lymphocytic, lymphoma, relapsed/refractory all, small lymphocytic lymphoma
