- ICH GCP
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- Ensayo clínico NCT01403948
BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 12200
- Charité - Universitätsmedizin Berlin
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Dresden, Alemania, 01307
- Universitätsklinikum Carl Gustav Carus Dresden
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Frankfurt am Main, Alemania, 60590
- Universitätsklinikum Frankfurt
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Göttingen, Alemania, 37075
- Universitätsmedizin Göttingen, Georg-August-Universität
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Hamburg, Alemania, 20099
- Asklepios Klinik St. Georg
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Heidelberg, Alemania, 69120
- Universitätsklinikum Heidelberg
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Jena, Alemania, 07740
- Universitätsklinikum Jena
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Ulm, Alemania, 89081
- Universitatsklinikum Ulm
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Seoul, Corea, república de, 135-710
- Samsung Medical Center
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Seoul, Corea, república de, 110-744
- Seoul National University Hospital
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Marseille Cedex 09, Francia, 13273
- INS Paoli-Calmettes
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Pierre Bénite, Francia, 69495
- HOP Lyon Sud
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
- Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
- Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
- Relapse or progression of disease with an indication for therapy as per investigator's judgement
- Life expectancy of =3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion criteria:
- Primary central nervous system (CNS) lymphoma or known CNS involvement
- Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
- Last chemotherapy <4 weeks prior to visit 1
- Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
- Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
- High-dose therapy with stem cell support <6 months prior to visit 1
- Radio-immunotherapy <3 months prior to visit 1
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
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Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
Periodo de tiempo: From the first administration of trial medication to 7 days after the second administration, upto 36 days
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The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients.
The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course.
In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration..
A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
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From the first administration of trial medication to 7 days after the second administration, upto 36 days
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Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
Periodo de tiempo: From the first administration of trial medication to 7 days after the second administration, up to 36 days
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Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
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From the first administration of trial medication to 7 days after the second administration, up to 36 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Tumour Size Reduction
Periodo de tiempo: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD).
Negative value represents decrease in tumour size, & positive value represents an increase in size.
The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan.
Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan.
If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions.
Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.
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Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Best Overall Response Based on All Assessment
Periodo de tiempo: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
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Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
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Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
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Best Overall Response Based on Imaging Data
Periodo de tiempo: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
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Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Progression Free Survival (PFS)
Periodo de tiempo: from first treatment until disease progression or death from any cause, up to 12 months.
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PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. |
from first treatment until disease progression or death from any cause, up to 12 months.
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Failure Free Survival (FFS)
Periodo de tiempo: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
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FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. |
from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1270.2
- 2010-024456-29 (Número EudraCT)
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Ensayos clínicos sobre Linfoma No Hodgkin
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Rutgers, The State University of New JerseyTerminadoMBSR-STEM | PMR-STEM | MBSR-NON-STEM | PMR - SIN VÁSTAGOEstados Unidos
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National Cancer Institute (NCI)TerminadoLinfoma de Hodgkin en adultos recidivante | Linfoma de Hodgkin en adultos en estadio III | Linfoma de Hodgkin en adultos en estadio IV | Linfoma de Hodgkin infantil recidivante/refractario | Linfoma de Hodgkin infantil en estadio III | Linfoma de Hodgkin infantil en estadio IV | Linfoma de Hodgkin... y otras condicionesEstados Unidos
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University of WashingtonReclutamientoLinfoma de Hodgkin recurrente | Linfoma de Hodgkin refractario | Linfoma no Hodgkin recurrente | Linfoma no Hodgkin refractarioEstados Unidos
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminadoLinfoma de Hodgkin recurrente | Linfoma de Hodgkin refractario | Linfoma no Hodgkin de células B refractario | Linfoma no Hodgkin de células T refractario | Linfoma no Hodgkin de células B recurrente | Linfoma no Hodgkin de células T recurrenteEstados Unidos
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Tomsk National Research Medical Center of the Russian...Uppsala UniversityTerminadoLinfoma de Hodgkin en adultos | Linfoma no Hodgkin en adultosFederación Rusa
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Marker Therapeutics, Inc.ReclutamientoNo linfoma de Hodgkin | Linfoma no Hodgkin en adultos | Linfoma no Hodgkin, refractario | Linfoma no Hodgkin en recaídaEstados Unidos
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Activo, no reclutandoLinfoma de Hodgkin en estadio III de Ann Arbor | Linfoma de Hodgkin en estadio IIIA de Ann Arbor | Linfoma de Hodgkin en estadio IIIB de Ann Arbor | Linfoma de Hodgkin en estadio IV de Ann Arbor | Linfoma de Hodgkin en estadio IVA de Ann Arbor | Linfoma de Hodgkin en estadio IVB de Ann Arbor | Linfoma... y otras condicionesEstados Unidos
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Tessa TherapeuticsActivo, no reclutandoLinfoma de Hodgkin en adultos | Enfermedad de Hodgkin Recurrente | Enfermedad de Hodgkin refractario | Enfermedad de Hodgkin, PediátricaEstados Unidos
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Activo, no reclutandoLinfoma de Hodgkin refractario | Linfoma no Hodgkin de células B refractario | Linfoma no Hodgkin de células T refractario | Receptor de trasplante de células hematopoyéticasEstados Unidos
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Stanford UniversityNational Institutes of Health (NIH); AmgenTerminadoLinfoma No Hodgkin | Linfomas: no Hodgkin | Linfomas: células T periféricas no Hodgkin | Linfomas: linfoma cutáneo no Hodgkin | Linfomas: células B grandes difusas no Hodgkin | Linfomas: folicular no Hodgkin/células B indolentes | Linfomas: células del manto no Hodgkin | Linfomas: Zona Marginal No... y otras condicionesEstados Unidos
Ensayos clínicos sobre BI 836826
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Boehringer IngelheimTerminadoLeucemia Linfocítica Crónica De Células BAlemania, Bélgica, Francia
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Boehringer IngelheimTerminadoLeucemia Linfocítica Crónica De Células BEstados Unidos
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Boehringer IngelheimRetiradoLeucemia Linfocítica Crónica De Células B
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Boehringer IngelheimTerminadoLinfoma de células B grandes, difusoEspaña, Italia, Bélgica
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Gilead SciencesBoehringer IngelheimTerminadoEstudio de idelalisib en combinación con BI 836826 en participantes con leucemia linfocítica crónicaLeucemia linfocítica crónica (LLC)Estados Unidos
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Boehringer IngelheimTerminado
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Boehringer IngelheimReclutamientoMelanoma | Cáncer de pulmón de células no pequeñas (CPCNP) | Carcinoma de células escamosas de cabeza y cuello (HNSCC)Países Bajos
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Boehringer IngelheimAún no reclutando
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Boehringer IngelheimReclutamientoTumores sólidosHungría