Resumen del Estudio
Este estudio clínico de Fase 3 está dirigido a personas recién diagnosticadas con Leucemia Linfocítica Crónica (LLC) o Linfoma Linfocítico Pequeño (LLP) que requieren iniciar tratamiento y no han recibido terapias oncológicas anteriores. El objetivo principal es comparar la eficacia del fármaco en investigación, Nemtabrutinib, frente a los tratamientos estándar actuales (Ibrutinib o Acalabrutinib). Los investigadores buscan determinar si Nemtabrutinib es capaz de reducir la enfermedad con la misma eficacia que los medicamentos actuales (no inferioridad) y si logra mantener a los pacientes libres de progresión de la enfermedad por más tiempo (superioridad). Todos los medicamentos del estudio son de administración oral. Desde una perspectiva médica integral, es relevante destacar que el estudio permite la inclusión de pacientes con antecedentes de Hepatitis B o C, siempre que la infección esté controlada (carga viral indetectable) y bajo tratamiento antiviral adecuado, ofreciendo una opción terapéutica a poblaciones con estas comorbilidades hepáticas.
Criterios de Elegibilidad
Resumen de Elegibilidad:Criterios de Inclusión: Diagnóstico confirmado de LLC/LLP con necesidad de tratamiento, sin terapia sistémica previa, capacidad de tragar medicamentos orales. Se aceptan pacientes con Hepatitis B o C controlada (carga viral indetectable). Criterios de Exclusión: Infección activa de Hepatitis B/C, disfunción gastrointestinal severa, problemas cardíacos clínicamente significativos, transformación de Richter o compromiso del sistema nervioso central.
- Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
- Has at least 1 marker of disease burden.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
- Has the ability to swallow and retain oral medication.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
- Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
- Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
- Has clinically significant cardiovascular disease.
- Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
- Has history of severe bleeding disorder.
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has received any systemic anticancer therapy for CLL/SLL.
- Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
- Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.