A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
17 de noviembre de 2014 actualizado por: Hoffmann-La Roche
Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma.
Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response).
The anticipated time on study treatment is <3 months.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
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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Erlangen, Alemania, 91054
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Grenzach-wyhlen, Alemania, 79639
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Göttingen, Alemania, 37075
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Hannover, Alemania, 30625
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Homburg/saar, Alemania, 66424
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Köln, Alemania, 50924
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Muenchen, Alemania, 80336
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Muenchen, Alemania, 81377
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Muenster, Alemania, 48129
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Stuttgart, Alemania, 70376
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Tübingen, Alemania, 72076
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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 patients >= 18 years of age;
- centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
- relapse after chemotherapy (with or without interferon maintenance therapy).
Exclusion Criteria:
- primary refractory lymphomas;
- more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
- clinically significant cardiac disease.
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: No aleatorizado
- 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: MabThera/Rituxan
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375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
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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 a Complete Remission (CR) or Partial Remission (PR)
Periodo de tiempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4).
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL.
PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With a Clinical Response
Periodo de tiempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD).
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Time to Best Response
Periodo de tiempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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The median time, in months, from start of the treatment (first application) until best response (PR or CR).
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Duration of Remission
Periodo de tiempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Median time, in months, between the documentation of CR or PR and PD in clinical responders.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Time to Progression
Periodo de tiempo: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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The median time, in months, from the start of treatment (first application) until detection of PD.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Overall Survival (OS)
Periodo de tiempo: Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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OS was defined as the time, in months, between enrollment into the study and death, due to any cause.
Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
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Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Number of Participants With a Clinical Response to Re-Treatment
Periodo de tiempo: First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
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Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD.
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
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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 enero de 1997
Finalización primaria (Actual)
1 de febrero de 2008
Finalización del estudio (Actual)
1 de febrero de 2008
Fechas de registro del estudio
Enviado por primera vez
25 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
25 de noviembre de 2013
Publicado por primera vez (Estimar)
2 de diciembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de diciembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
17 de noviembre de 2014
Última verificación
1 de octubre de 2014
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
- Linfoma
- Linfoma No Hodgkin
- Efectos fisiológicos de las drogas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Factores inmunológicos
- Agentes antineoplásicos inmunológicos
- Rituximab
Otros números de identificación del estudio
- M39004
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. .