Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma
23 de enero de 2017 actualizado por: Janssen Pharmaceutical K.K.
A Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
The purpose of this study is to evaluate overall response rate (ORR) (complete response [CR] rate plus partial response [PR] rate) of ibrutinib (IMBRUVICA™; PCI-32765; JNJ-54179060), as assessed by an Independent Review Committee (IRC), in participants with relapsed or refractory mantle cell lymphoma (MCL-a cancer of the lymph nodes or tissues).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase 2, single-arm, open-label (all knew the intervention of study), and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to explore the efficacy, safety and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of ibrutinib in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) MCL.
The study will consist of a Screening Phase of 30 days prior to first dose of study drug followed by treatment Phase and a post-treatment follow-up Phase.
Participants will receive ibrutinib 560 milligram (mg) orally, once daily on a 28-day cycle until disease progression (or relapse if the participant achieved a CR), unacceptable toxicity, or study end, whichever occurs first.
Treatment Phase will have disease assessments every 8 weeks up to 24 weeks after start of study drug, then every 12 weeks thereafter to assess efficacy up to 2 years after last participant enrolled.
Efficacy will primarily be evaluated by ORR.
Participants' safety will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
16
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
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Fukuoka, Japón
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Isehara, Japón
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Kobe, Japón
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Kyoto, Japón
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Nagoya, Japón
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Osaka, Japón
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Sendai, Japón
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Tokyo, Japón
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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
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of mantle cell lymphoma ( MCL) must include morphology and expression of either cyclin D1 in association with one B-cell marker (for example, cluster of differentiation [CD] CD19, CD20, or paired box [PAX5]) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
- Received at least 1 prior lines of therapy for MCL (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval)
- At least 1 measurable site of disease according to the Revised Response Criteria for Malignant Lymphoma (that is, the site of disease must be greater than 1.5 centimeter [cm] in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions)
- Have documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent anti-MCL treatment regimen
- Eastern Cooperative Oncology Group performance status score of 0 or 1
Exclusion Criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
- Prior treatment with ibrutinib or other Bruton's Tyrosine Kinase (BTK) inhibitors
- More than 5 prior lines of therapy for MCL (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval)
- Known central nervous system (CNS) lymphoma
- Woman who is pregnant, breast-feeding, or planning to become pregnant within 1 month after the last dose of study drug or is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
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 |
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Experimental: Ibrutinib
Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
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Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Overall Response
Periodo de tiempo: Up to 2 years after last participant enrolled
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Overall response is defined as achievement of complete response (CR) or partial response (PR), as assessed by the Independent Review Committee (IRC), based on the Revised Response Criteria for Malignant Lymphoma.
CR is: a) disappearance of all detectable disease symptoms and signs; b) lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size; c) negative positron emission tomography (PET) scan; d) normal sized spleen or liver if enlarged before therapy; d) bone marrow infiltrate must be cleared if would have been involved before treatment; e) no new sites of disease.
PR is: a) greater than 50 percent decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, splenic and hepatic nodules; b) no increase in the size of other nodes, liver, or spleen, c) no measurable disease in other organs; d) no new sites of disease; e) 1 PET-positive site of disease (required for the CT+PET assessment of PR).
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Up to 2 years after last participant enrolled
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Duration of Response
Periodo de tiempo: Up to 2 years after last participant enrolled
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Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
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Up to 2 years after last participant enrolled
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Time to Response
Periodo de tiempo: Up to 2 years after last participant enrolled
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Time to response is the time from the date of first dose of study drug until the first date of initial documentation of a response (CR or PR).
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Up to 2 years after last participant enrolled
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Overall Survival (OS)
Periodo de tiempo: Up to 2 years after last participant enrolled
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The OS is defined as the time from the date of first dose of study drug to date of death from any cause.
If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
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Up to 2 years after last participant enrolled
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Progression-free Survival (PFS)
Periodo de tiempo: Up to 2 years after last participant enrolled
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The PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
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Up to 2 years after last participant enrolled
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: Day 1 up to 30 days after last dose administration
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An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
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Day 1 up to 30 days after last dose administration
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Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
Periodo de tiempo: Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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The AUC (0-last) is the area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
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Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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Apparent Clearance (CL/F)
Periodo de tiempo: Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration.
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Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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Minimum Observed Plasma Concentration (Cmin)
Periodo de tiempo: Predose (0) and 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and Cycle 2
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Minimum Observed Plasma Concentration (Cmin) will be observed.
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Predose (0) and 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and Cycle 2
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de agosto de 2014
Finalización primaria (Actual)
1 de noviembre de 2016
Finalización del estudio (Actual)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de junio de 2014
Publicado por primera vez (Estimar)
23 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de enero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
23 de enero de 2017
Última verificación
1 de enero de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR104615
- PCI-32765MCL2002 (Otro identificador: Janssen Pharmaceutical K.K., Japan)
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. .
Ensayos clínicos sobre Linfoma De Células Del Manto
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Adelphi Values LLCBlueprint Medicines CorporationTerminadoLeucemia de mastocitos (LCM) | Mastocitosis Sistémica Agresiva (ASM) | SM w Asoc Clonal Hema Non-mast Cell Linage Disease (SM-AHNMD) | Mastocitosis sistémica latente (MSS) | Mastocitosis Sistémica Indolente (ISM) Subgrupo ISM Completamente ReclutadoEstados Unidos
Ensayos clínicos sobre Ibrutinib
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Christian BuskeAmgen; Janssen, LPReclutamientoMacroglobulinemia de WaldenströmAustria, Alemania, Grecia
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Oncternal Therapeutics, IncUniversity of California, San Diego; Pharmacyclics LLC.; California Institute for...Activo, no reclutandoLinfoma de células del manto | Linfoma de zona marginal | Leucemia linfocítica crónica de células B | Linfoma de linfocitos pequeñosEstados Unidos
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The Lymphoma Academic Research OrganisationJanssen Pharmaceutica N.V., BelgiumTerminadoLinfoma de células BFrancia, Bélgica
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Pharmacyclics Switzerland GmbHJanssen Biotech, Inc., including Johnson & JohnsonInscripción por invitaciónLinfoma de células B | Linfoma No Hodgkin | Tumor solido | Leucemia de células B | Enfermedad de injerto contra huéspedEstados Unidos, España, Taiwán, Reino Unido, Australia, Italia, Federación Rusa, Canadá, Nueva Zelanda, Corea, república de, Francia, Pavo, Chequia, Hungría, Polonia, Suecia
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