Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
2 de julio de 2015 actualizado por: GlaxoSmithKline
An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant
The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
81
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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London, Reino Unido, EC1M 6BQ
- GSK Investigational Site
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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:
Patients with DLBCL
- and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
- and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
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: Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
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8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Objective Response
Periodo de tiempo: 6-month period from start of treatment (up to Week 24)
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Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma."
Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease.
CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
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6-month period from start of treatment (up to Week 24)
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Number of Participants Classified as Responders and Non-responders for Objective Response
Periodo de tiempo: 6-month period from start of treatment (up to Week 24)
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According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD).
Participants not evaluable (NE) were also considered to be non-responders.
PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline.
SD is defined as failure to attain CR, PR, or PD.
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6-month period from start of treatment (up to Week 24)
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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: From date of start of treatment to 2 years or withdrawal
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The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death.
If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
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From date of start of treatment to 2 years or withdrawal
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Progression-free Survival (PFS)
Periodo de tiempo: From date of start of treatment to 2 years or withdrawal
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PFS was defined as the time from treatment start until progression or death.
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From date of start of treatment to 2 years or withdrawal
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Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
Periodo de tiempo: From date of start of treatment to 5 years or withdrawal
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Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab.
If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
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From date of start of treatment to 5 years or withdrawal
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Overall Survival (OS)
Periodo de tiempo: From date of start of treatment to 5 years or withdrawal
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Overall survival is defined as the time from first infusion to death.
Overall survival was a secondary endpoint in the study.
However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.
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From date of start of treatment to 5 years or withdrawal
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Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Periodo de tiempo: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
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HAHA are indicators of immune response to ofatumumab.
Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches.
The number of participants with positive results at each visit is reported.
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Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
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Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
Periodo de tiempo: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
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B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry.
Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.
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Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
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Number of Participants Who Experienced at Least One Adverse Event (AE)
Periodo de tiempo: Time frame is from date of start of treatment to 2 years or withdrawal
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An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).
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Time frame is from date of start of treatment to 2 years or withdrawal
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Percent Change From Screening in Complement (CH50) Levels
Periodo de tiempo: Screening and post-baseline visits (last visit was to occur 24 months post first dose)
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CH50 was mistakenly registered as an outcome measure with the protocol record.
Samples were not collected, and no analysis will take place.
Thus, no data will be reported for this outcome measure.
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Screening and post-baseline visits (last visit was to occur 24 months post first dose)
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AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
Periodo de tiempo: Visit 9 (Week 7; up to 11 months after last dose)
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AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure.
AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.
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Visit 9 (Week 7; up to 11 months after last dose)
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Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
Periodo de tiempo: Visit 2 (Week 0) and Visit 9 (Week 7)
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Cmax is defined as the maximum concentration of drug in serum samples.
Ctrough is defined as the minimum observed concentration prior to the start of the next dose.
No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.
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Visit 2 (Week 0) and Visit 9 (Week 7)
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Half-life (T1/2) for Ofatumumab at the Eighth Infusion
Periodo de tiempo: Visit 9 (Week 7; up to 11 months after last dose)
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t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.
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Visit 9 (Week 7; up to 11 months after last dose)
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Clearance (CL) of Ofatumumab at the Eighth Infusion
Periodo de tiempo: Visit 9 (Week 7; up to 11 months after last dose)
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CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.
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Visit 9 (Week 7; up to 11 months after last dose)
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Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
Periodo de tiempo: Visit 9 (Week 7; up to 11 months after the last dose)
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Vss is the volume of distribution at steady state of ofatumumab.
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Visit 9 (Week 7; up to 11 months after the last dose)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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 diciembre de 2007
Finalización primaria (Actual)
1 de mayo de 2010
Finalización del estudio (Actual)
1 de agosto de 2014
Fechas de registro del estudio
Enviado por primera vez
13 de febrero de 2008
Primero enviado que cumplió con los criterios de control de calidad
13 de febrero de 2008
Publicado por primera vez (Estimar)
25 de febrero de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2015
Última verificación
1 de enero de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 111776
- GEN415 (Otro identificador: Genmab)
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. .