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Un estudio para evaluar el efecto de Venetoclax en participantes que reciben un inhibidor de tirosina quinasa covalente de Bruton (cBTKi) para la leucemia linfocítica crónica de primera línea (1L CLL) para lograr remisiones profundas y duraderas que permitan el período sin tratamiento (BRAVE)

25 de septiembre de 2026 actualizado por: Genentech, Inc.

Ensayo clínico multicéntrico, prospectivo, de etiqueta abierta, de fase II para evaluar si la adición de Venetoclax a pacientes con BTKi covalente para 1 litro de CLL puede lograr remisiones profundas y duraderas (según UMRD 10^-4) para permitir un período sin tratamiento

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period.

The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

118

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Arkansas
      • Springdale, Arkansas, Estados Unidos, 72762
        • Highlands Oncology Group
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80012-5405
        • Rocky Mountain Cancer Centers (Aurora) - USOR
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32256-6932
        • Cancer Specialists of North Florida
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46804
        • Fort Wayne Medical Oncology and Hematology, Inc
    • Iowa
      • Des Moines, Iowa, Estados Unidos, 50314-3030
        • Mission Blood and Cancer - MercyOne Cancer Center
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20817-1915
        • American Oncology Partners of Maryland, PA
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215-5418
        • Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center
    • Nebraska
      • Grand Island, Nebraska, Estados Unidos, 68803
        • Nebraska Cancer Specialists St Francis - Grand Island
      • Omaha, Nebraska, Estados Unidos, 68130-2042
        • Nebraska Cancer Specialists
    • New Jersey
      • East Brunswick, New Jersey, Estados Unidos, 08816-4096
        • Astera Cancer Care East Brunswick
    • New Mexico
      • Farmington, New Mexico, Estados Unidos, 87401
        • San Juan Oncology Associates, PC
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45236-2725
        • Oncology Hematology Care Inc - Cincinnati - USOR
      • Columbus, Ohio, Estados Unidos, 43210
        • Ohio State University
    • Oregon
      • Eugene, Oregon, Estados Unidos, 97401-6043
        • Willamette Valley Cancer Institute and Research Center
      • Medford, Oregon, Estados Unidos, 97504-8332
        • Asante Rogue Regional Medical Center
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Tennessee Oncology, PLLC - Chattanooga
      • Nashville, Tennessee, Estados Unidos, 37203
        • Tennessee Oncology - Midtown
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • MD Anderson Cancer Center
      • Tyler, Texas, Estados Unidos, 75702
        • Texas Oncology- Northeast Texas
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
  2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 2
  3. Adequate renal and liver function

Exclusion Criteria:

  1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy
  2. Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
  3. Progressive or stable disease on cBTKi
  4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
  5. History of cardiomyopathy
  6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
  7. Clinically significant cardiovascular disease
  8. Active bleeding or history of bleeding diathesis
  9. Pregnant women and nursing mothers
  10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Venetoclax Added to cBTKi (Commercially Prescribed)

Participants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Week 5 up to Day 28 of Cycle 12. Participant will discontinue from venetoclax and/or cBTKi after 12 cycles. Participants with detectable measurable residual disease with the presence of less than 1 CLL cell in 10,000 leukocytes (< 10^-4) (MRD4) or uMRD4 with partial response (PR) may continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label.
Droga: Venetoclax

Venetoclax tablets will be administered as per the schedule specified in the arm.

Otros nombres:
  • RO5537382
Droga: cBTKi Monotherapy

Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
uMRD4 Rate at EOCT
Periodo de tiempo: Cycle 12 Day 28 (Cycle length= 28 Days)

uMRD4 will be assessed using next generation sequencing (NGS) (sensitivity 10^-4) from PB.
Cycle 12 Day 28 (Cycle length= 28 Days)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
CR/CRi Rate at EOCT as Determined by the Investigator According to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines
Periodo de tiempo: Up to approximately 12 months

Complete response (CR)/complete response with incomplete recovery of the bone marrow (CRi) rate is defined as the percentage of participants with a CR or CRi at EOCT, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
PR Rate at EOCT as Determined by the Investigator According to iwCLL Guidelines
Periodo de tiempo: Up to approximately 12 months

PR rate is defined as the percentage of participants with a PR at EOCT, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
Overall Response Rate (ORR) at EOCT as Determined by the Investigator According to iwCLL Guidelines
Periodo de tiempo: Up to approximately 12 months

ORR is defined as the percentage of participants with a CR/CRi or PR at EOCT, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Up to approximately 13 months

AE and SAEs will be collected as part of this study at baseline and every clinical visit, until 30 days after the final dose of study treatment.
Up to approximately 13 months
Number of Participants Who Withdrew Prematurely from the Study
Periodo de tiempo: Up to approximately 12 months

Participants who discontinued treatment before Cycle 12 Day 28 (cycle length= 28 days).
Up to approximately 12 months
Overall Survival (OS)
Periodo de tiempo: Up to approximately 48 months

OS is defined as the time from the first study treatment to death from any cause.
Up to approximately 48 months
Progression-free Survival (PFS) as Determined by the Investigator According to iwCLL Guidelines
Periodo de tiempo: Up to approximately 48 months

PFS is defined as the time from the first study treatment to the first occurrence of disease progression (PD) or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 48 months
Event-free Survival (EFS) as Determined by the Investigator According to iwCLL Guidelines
Periodo de tiempo: Up to approximately 48 months

EFS is defined as the time from the first study treatment to the first occurrence of PD, anti-leukemic treatment subsequent to the study treatment, or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 48 months
Duration of Response (DOR) in Participants With CR/CRi or PR as Determined by the Investigator According to iwCLL Guidelines
Periodo de tiempo: Up to approximately 12 months

DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR/CRi or PR) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
DOR in Participants With CR or CRi as Determined by the Investigator According to iwCLL Guidelines
Periodo de tiempo: Up to approximately 12 months

DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR or CRi ) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL.
Up to approximately 12 months
Time to Next CLL Treatment (TTNT)
Periodo de tiempo: Up to approximately 12 months

TTNT is defined as the time from the first study treatment to the start of anti-leukemic treatment subsequent to the study treatment or death, whichever occurs first.
Up to approximately 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Genentech, Inc.

Investigadores

  • Director de estudio: Clinical Trials, Hoffmann-La Roche

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de agosto de 2024

Finalización primaria (Estimado)

31 de octubre de 2026

Finalización del estudio (Estimado)

31 de enero de 2030

Fechas de registro del estudio

Enviado por primera vez

23 de julio de 2024

Primero enviado que cumplió con los criterios de control de calidad

23 de julio de 2024

Publicado por primera vez (Actual)

29 de julio de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML45219

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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