- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00073749
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
14 de diciembre de 2018 actualizado por: Pfizer
A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
79
Fase
- Fase 1
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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Mainz, Alemania, 55131
- Universitaetsmedizin der Johannes Gutenberg-Universitaet
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Muenchen, Alemania, 81377
- Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern
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Muenchen, Alemania, 81377
- Universitaet Muenchen Klinikum Grosshadern
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NRW
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Bonn, NRW, Alemania, 53105
- Universitätsklinikum Bonn
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Leuven, Bélgica, 3000
- Universitair Ziekenhuis Gasthuisberg
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Barcelona, España, 08025
- Hospital de la Santa Creu i Sant Pau
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Barcelona, España, 08036
- Hospital Clinic I Provincial
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Estados Unidos, 35233
- UAB CCC Clinical Studies Unit
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham Kirklin Clinic
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Birmingham, Alabama, Estados Unidos, 35294
- UAB Russell Ambulatory Pharmacy
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Medical Faculty Foundation
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New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, Estados Unidos, 77030-4009
- M.D. Anderson Cancer Center
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Paris, Francia, 75010
- Hôpital Saint Louis
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Pierre Benite Cedex, Francia, 69495
- Centre Hospitalier Lyon-Sud
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London, Reino Unido, EC1A 7BE
- St Bartholomew's Hospital
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Lausanne, Suiza, 1011
- Centre Hospitalier Universitaire Vaudois
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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 a 99 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
- At the expanded cohort, part 2 of the study, subjects must have one of the following:
- Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
- Diffuse large B-cell lymphoma
- Age 18 years or older
Exclusion Criteria:
- Candidate for potentially curative therapies in the opinion of the investigator
- Chronic lymphocytic leukemia
- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
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
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
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CMC-544, IV, dose escalation trial
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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 Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline up to 42 days after last dose of study drug (up to Day 225)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was 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; congenital anomaly.
Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period.
AEs included both SAEs and non-serious adverse events (non-SAEs).
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Baseline up to 42 days after last dose of study drug (up to Day 225)
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Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity
Periodo de tiempo: Baseline up to 42 days after last dose of study drug (up to Day 225)
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AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study.
AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE).
Participants with Grade 3 or higher grades TEAEs were reported.
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Baseline up to 42 days after last dose of study drug (up to Day 225)
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Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)
Periodo de tiempo: Baseline up to Day 28
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MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT).
DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.
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Baseline up to Day 28
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Number of Participants With Dose-limiting Toxicity (DLT)
Periodo de tiempo: Baseline up to Day 28
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DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.
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Baseline up to Day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Periodo de tiempo: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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PFS was based on Kaplan-Meier estimates.
PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
Periodo de tiempo: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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PFS was based on Kaplan-Meier estimates.
PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Periodo de tiempo: Baseline up to Year 5
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OS was based on Kaplan-Meier method.
Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline up to Year 5
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Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
Periodo de tiempo: Baseline up to Year 5
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Interval OS was based on Kaplan-Meier method.
Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline up to Year 5
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Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
Periodo de tiempo: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
Periodo de tiempo: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
Periodo de tiempo: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
Periodo de tiempo: Baseline up to 42 days after last dose (Day 225)
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Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
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Baseline up to 42 days after last dose (Day 225)
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Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
Periodo de tiempo: Baseline up to 42 days after last dose of study drug (Day 225)
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Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
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Baseline up to 42 days after last dose of study drug (Day 225)
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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 (Actual)
1 de agosto de 2003
Finalización primaria (Actual)
1 de diciembre de 2010
Finalización del estudio (Actual)
1 de diciembre de 2010
Fechas de registro del estudio
Enviado por primera vez
4 de diciembre de 2003
Primero enviado que cumplió con los criterios de control de calidad
4 de diciembre de 2003
Publicado por primera vez (Estimar)
5 de diciembre de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
14 de diciembre de 2018
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Linfoma de células B
- Linfoma No Hodgkin
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Antibióticos, Antineoplásicos
- Inotuzumab Ozogamicina
Otros números de identificación del estudio
- 3129K1-100
- B1931002 (Otro identificador: Alias Study Number)
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 B
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Northwestern UniversityNational Cancer Institute (NCI)Activo, no reclutandoLinfoma difuso de células B grandes | Linfoma difuso de células B grandes, no especificado | Linfoma de células B de alto grado, no especificado | Linfoma de células B grandes ricas en histiocitos/células T | Linfoma de células B de alto grado con reordenamientos de MYC y BCL2 y/o BCL6 | Linfoma... y otras condicionesEstados Unidos
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Nathan DenlingerBristol-Myers SquibbReclutamientoLinfoma no Hodgkin de células B recurrente | Linfoma difuso de células B grandes recurrente | Linfoma folicular recurrente | Linfoma de células B de alto grado recurrente | Linfoma primario mediastínico de células B grandes recurrente | Linfoma no Hodgkin de células B indolentes transformado... y otras condicionesEstados Unidos
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Northwestern UniversityNational Cancer Institute (NCI)ReclutamientoLinfoma de células B grandes mediastínico primario (tímico) recidivante | Linfoma de células B grandes del mediastino primario (tímico) refractario | Linfoma recurrente de células B de alto grado con reordenamientos de MYC, BCL2 y BCL6 | Linfoma refractario de células B de alto grado con... y otras condicionesEstados Unidos
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Lapo AlinariReclutamientoLinfoma recurrente de células B de alto grado con reordenamientos de MYC, BCL2 y BCL6 | Linfoma refractario de células B de alto grado con reordenamientos de MYC, BCL2 y BCL6 | Linfoma recurrente de células B de alto grado con reordenamientos de MYC y BCL2 o BCL6 | Linfoma refractario... y otras condicionesEstados Unidos
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National Cancer Institute (NCI)ReclutamientoLinfoma de células B de alto grado | Linfoma difuso de células B grandes, no especificado | Linfoma no Hodgkin de células B indolente transformado en linfoma difuso de células B grandesEstados Unidos
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National Cancer Institute (NCI)Activo, no reclutandoLinfoma de células B grandes difuso recurrente tipo de células B activadas | Linfoma de células B grandes difuso refractario tipo de células B activadasEstados Unidos, Arabia Saudita
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Curocell Inc.ReclutamientoLinfoma de células B de alto grado | Linfoma difuso de células B grandes (DLBCL) | Linfoma primario de células B grandes del mediastino (PMBCL) | Linfoma folicular transformado (TFL) | Linfoma de células B grandes refractario | Linfoma de células B grandes en recaídaCorea, república de
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Ohio State University Comprehensive Cancer CenterReclutamientoLinfoma difuso de células B grandes | Linfoma de células B de alto grado | Linfoma difuso de células B grandes, no especificado | Linfoma difuso de células B grandes Centro germinal Tipo de células BEstados Unidos
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenActivo, no reclutandoLinfoma difuso de células B grandes recidivante | Linfoma difuso de células B grandes refractario | CD20 positivo | Linfoma difuso de células B grandes en estadio I | Linfoma difuso de células B grandes en estadio II | Linfoma difuso de células B grandes en estadio III | Linfoma difuso de células...Estados Unidos
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Mayo ClinicNational Cancer Institute (NCI)ReclutamientoLinfoma no Hodgkin de células B recurrente | Linfoma de células B grandes mediastínico primario (tímico) recidivante | Linfoma recurrente de células B de alto grado con reordenamientos de MYC, BCL2 y BCL6 | Linfoma refractario de células B de alto grado con reordenamientos de MYC, BCL2... y otras condicionesEstados Unidos
Ensayos clínicos sobre Inotuzumab ozogamicin [CMC-544]
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Wyeth is now a wholly owned subsidiary of PfizerTerminado
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Institute of Hematology & Blood Diseases HospitalAún no reclutando
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PfizerUCB PharmaTerminadoLeucemia linfocítica agudaEstados Unidos
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PfizerTerminadoLeucemia-linfoma linfoblástico de células precursorasReino Unido
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminadoLeucemia linfoblástica aguda recurrente | Leucemia linfoblástica aguda refractaria | CD22 positivoEstados Unidos
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PfizerTerminado
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M.D. Anderson Cancer CenterWyeth is now a wholly owned subsidiary of PfizerTerminadoLeucemia linfoblástica agudaEstados Unidos
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PfizerUCB PharmaTerminadoLinfoma de células BEstados Unidos, Bélgica, Corea, república de, Suiza, Francia, Polonia, España, Hong Kong, Australia, Alemania, Italia, Países Bajos, Reino Unido
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ReclutamientoLeucemia linfoblástica aguda | B Leucemia linfoblástica aguda | Leucemia linfoblástica aguda B recurrenteEstados Unidos
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Cristiana SessaTerminadoLinfoma de células B refractarioSuiza