POLARYS 2 A Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia
Edad ≥ 18 años.
Diagnóstico de LMC-CP.
Parte A: Tratamiento previo con al menos dos TKI aprobados. Parte B: Mutación T315I en la selección.
Estado funcional (PS) del Eastern Cooperative Oncology Group (ECOG) ≤ 2.
Consentimiento informado por escrito obtenido antes de cualquier procedimiento de selección.
Pacientes con funciones orgánicas adecuadas.
For Part A only: T315I mutation at any time prior to starting study treatment.
Active infection that requires systemic drug therapy
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
Pregnant or nursing (lactating) women.
The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation
