Estudio de Fase 3, Abierto y Aleatorizado de Pirtobrutinib (LOXO-305) Versus Ibrutinib en Pacientes con Leucemia Linfocítica Crónica/Linfoma Linfocítico Pequeño (BRUIN-CLL-314)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05254743Tipo: INTERVENTIONALInicio: 22 de jul de 2022Fin estimado: 1 de ene de 2028

Resumen

El propósito de la Parte 1 de este estudio es comparar la eficacia y seguridad de pirtobrutinib (LOXO-305) frente a ibrutinib en participantes con LLC/LLP; los participantes pueden o no haber recibido tratamiento previo para su cáncer. El propósito de la Parte 2 de este estudio es evaluar la monoterapia con pirtobrutinib en participantes sin tratamiento previo con LLC/LLP con deleción 17p. La participación en la Parte 1 puede durar hasta seis años. La participación en la Parte 2 puede durar hasta 2 años.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate organ function
Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Criterios de exclusión

Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
Known or suspected central nervous system (CNS) involvement
A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
Active cytomegalovirus (CMV) infection
Active uncontrolled systemic bacterial, viral, or fungal infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
Ongoing inflammatory bowel disease
Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
Part 2: participants must be treatment naïve
Concurrent use of investigational agent or anticancer therapy except hormonal therapy
Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Use of \> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
Vaccination with a live vaccine within 28 days prior to randomization
Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Intervenciones

drug

Pirtobrutinib

Administered orally.

drug

Ibrutinib

Administered orally.

Ubicaciones

Alexander Fleming

Ciudad Autónoma de Buenos Aire, Argentina

RECRUITING

Hospital Privado De Comunidad

Mar del Plata, Argentina

ACTIVE_NOT_RECRUITING

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

Santa Fe, Argentina

RECRUITING

Patrocinadores

PrincipalLoxo Oncology, Inc.

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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