A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
30 de marzo de 2016 actualizado por: Hoffmann-La Roche
A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
34
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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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, 1406
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Buenos Aires, Argentina, C1114AAN
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Buenos Aires, Argentina, C1431FWO
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Córdoba, Argentina, 5016
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La Plata, Argentina, B1897GOL
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Pilar, Argentina, B1629ODT
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Rosario, Argentina, S2000DSV
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Caracas, Venezuela, 2122
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adult participants greater than or equal to (≥) 18 years of age
- B-cell CLL
- No previous treatment for leukemia
Exclusion Criteria:
- History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
- Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment
- Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)
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: Rituximab + Fludarabine + Cyclophosphamide
Participants will receive rituximab (375 milligrams per meter-squared [mg/m^2] intravenously [IV]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months.
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Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
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 Death or Disease Progression
Periodo de tiempo: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes.
The percentage of participants with death or documented disease progression at any time during the study was calculated.
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Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Progression-Free Survival (PFS)
Periodo de tiempo: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes.
PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.
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Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Percentage of Participants Who Died
Periodo de tiempo: Up to 5 years (from Baseline until death)
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Participants were followed for survival throughout the study.
The percentage of participants who died of any cause during the study was calculated.
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Up to 5 years (from Baseline until death)
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Overall Survival (OS)
Periodo de tiempo: Up to 5 years (from Baseline until death)
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Participants were followed for survival throughout the study.
OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis
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Up to 5 years (from Baseline until death)
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Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)
Periodo de tiempo: Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values.
Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR.
The percentage of participants with each level of best overall response was calculated.
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Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 febrero de 2006
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2015
Publicado por primera vez (Estimar)
26 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
30 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Leucemia de células B
- Leucemia
- Leucemia Linfocítica Crónica De Células B
- Leucemia Linfoide
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos inmunológicos
- Ciclofosfamida
- Rituximab
- Fludarabina
Otros números de identificación del estudio
- ML18429
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