Suspendido

Phase I/II Study of Anti-CTLA-4 Monoclonal Antibody (MDX-010) in B-cell Non-Hodgkin's Lymphoma

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

ipilimumab

+ laboratory biomarker analysis

BiológicoOtro
Quiénes están siendo reclutados

Linfoma Plasmablástico+33

+ Trastornos de las Proteínas Sanguíneas

+ Enfermedades Cardiovasculares

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1 & 2
Intervencional
Inicio del estudio: junio de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 13 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de junio de 2004

Fecha en la que se inscribió al primer participante.

PRIMARY OBJECTIVES: I. To characterize the safety profile of MDX-010 (ipilimumab) monoclonal antibody and identify a tolerable immunologically active dose level in B cell lymphoma patients. II. To evaluate the clinical response rate in B cell lymphoma patients treated with MDX-010. SECONDARY OBJECTIVES: I. To evaluate the phenotype and function of memory T cells before and after treatment with MDX-010 by: * Quantitation and phenotypic characterization of peripheral blood and tumor infiltrating T-cells, including cluster of differentiation (CD)4+CD25+ regulatory T cells. * Measurement of tumor-specific T cells in peripheral blood lymphocytes. * Measuring proliferation of memory T cells in response to recall antigens (tetanus toxoid and keyhole limpet hemocyanin \[KLH\]). II. Measurement of anti-tumor antibodies in serum pre- and post-therapy. III. To evaluate the time to progression. IV. To evaluate the duration of response to treatment with MDX-010. OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study. Patients are grouped according to prior treatment with a vaccine therapy for lymphoma (yes vs no). PHASE I: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive MDX-010 as in phase I at the MTD. Patients are followed at 1 and 4 months and then every 6 months for up to 2 years.

Título OficialPhase I/II Study of Anti-CTLA-4 Monoclonal Antibody (MDX-010) in B-cell Non-Hodgkin's Lymphoma 
NCT00089076
Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 13 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 18 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Linfoma PlasmablásticoTrastornos de las Proteínas SanguíneasEnfermedades CardiovascularesInfecciones por virus ADNNeoplasias ocularesLinfoma de BurkittTrastornos HemorrágicosInfecciones por HerpesviridaeEnfermedad CrónicaEnfermedades HematológicasEnfermedad de HodgkinEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosInfeccionesLeucemia LinfocíticaLeucemia de células peludasLeucemiaEnfermedades LinfáticasGranulomatosis linfomatoideLinfomaLinfoma no HodgkinTrastornos LinfoproliferativosLinfoma FolicularMacroglobulinemia de WaldenströmNeoplasiasNeoplasias por SitioNeoplasias por tipo histológicoParaproteinemiasProcesos PatológicosCondiciones PrecancerosasRecurrenciaInfecciones por Virus TumoralesEnfermedades VascularesEnfermedades ViralesLeucemia de células BLeucemia linfocítica crónica de células B

Criterios

Inclusion Criteria: * Histologic proof of recurring or residual follicular B-cell non-Hodgkin's lymphoma (grade I or II), by Revised European American Lymphoma Classification (REAL) or World Health Organization (WHO) classifications which has relapsed or persisted after 3 or fewer conventional therapies, including chemotherapy or monoclonal antibody therapy; note: all patients with previously treated B-cell lymphomas of any histology with the exception of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) are eligible * Tumor measurable by computed tomography (CT) scans (at least one pathologic node measuring 2.0 x 2.0 cm, or 2 nodes measuring \> 1.5 x 1.5 cm after collection of tumor for immunologic analyses) * At least one prior treatment regimen but no more than 3 prior chemotherapy regimens; patients previously treated with monoclonal antibodies or radiotherapy to a single site will be eligible; these therapies will be considered prior treatment regimens but will not be considered as prior chemotherapy; tumor vaccines will not be counted as prior therapies, as all such agents are investigational * Absolute neutrophil count (ANC) \>= 1000/uL * Platelets (PLT) \>= 75,000/uL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) =\< 3 x upper limit or normal (ULN) * Creatinine =\< 1.5 x ULN * Hemoglobin \>= 8 g/dL * Ability to provide informed consent * Willingness to return to the Mayo Clinic Rochester or the University of California, Los Angeles for follow up * Life expectancy \>= 24 weeks * Willingness to provide all biologic specimens as required by the protocol Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, 3, or 4 * Any uncontrolled infection, hepatitis C virus (HCV)+ (unless HCV ribonucleic acid \[RNA\]-negative by polymerase chain reaction \[PCR\]) or hepatitis B surface antigen (HBsAg)+, or human immunodeficiency virus (HIV) positive patients or patients with known immune deficiency states * Previous MDX-010 therapy regardless of interval since last treatment * Prior treatment with fludarabine or 2-chlorodeoxyadenosine =\< 12 months prior to registration * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * New York Heart Association classification III or IV or a history of angina pectoris requiring active treatment * Clinical evidence of central nervous system involvement by lymphoma * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) * Diagnosis of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) * Any requirement for concurrent steroid therapy, including use of inhaled steroids for asthma * History of autoimmune disease requiring systemic therapy with immunosuppressive drugs, including but not limited to rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, or psoriasis * Antinuclear antibody (ANA) titer or rheumatoid factor titer \> 3x institutional ULN

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
PHASE I: Patients receive MDX-010 IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive MDX-010 as in phase I at the MTD.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Mayo Clinic

Rochester, United StatesVer ubicación
Suspendido1 Centros de Estudio