A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)
HCD122
Enfermedades hemáticas y linfáticas+7
+ Enfermedad de Hodgkin
+ Enfermedades del sistema inmunitario
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2008
Fecha en la que se inscribió al primer participante.This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 111 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: * Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification * Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy) * Patients must be ≥ 18 years * Patients must have life expectancy \> 3 months * Patient must have adequate laboratory results * Patients must have WHO Performance Status grade 0, 1, or 2 * Patients must have at least one site of measurable disease * Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment. * Patients must be willing and able to sign the informed consent form and comply with the study protocol Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: * Patients who have been treated with any anti-CD40 antibody * Patients who have received prior allogeneic stem cell transplant * Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration * Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis * Women of child-bearing potential (WCBP) who are pregnant or breast feeding. Other protocol-defined inclusion/exclusion criteria may apply
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
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 28 ubicaciones
Northwestern University
Chicago, United StatesSt. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
Beech Grove, United StatesDana Farber Cancer Institute SC-5
Boston, United States