Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Colección de datos
Recopilados a partir de historiales médicos y datos pasados - RetrospectivoEnfermedades de la Médula Ósea+9
+ Enfermedades hemáticas y linfáticas
+ Enfermedad Crónica
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 8 de junio de 2005
Fecha en la que se inscribió al primer participante.PATIENT POPULATION: All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with any tyrosine kinase inhibitor (eg, imatinib, dasatinib, nilotinib) regardless of prior treatment history that has had at least one clinic visit at MDACC will be eligible. STUDY PLAN: The following information will be collected: * Demographic information including age, gender, ethnicity, education, and work history. * All laboratory values obtained at MDACC or other institutions, including CBC, blood chemistries, electrolytes, bone marrow aspirations and biopsies, cytogenetic analyses, mutation analysis, FISH, and PCR, and other tests obtained during regular care of these patients. * Treatment history including starting and stopping dates, doses, treatment interruptions, dose changes and reasons for dose modifications. * Information about toxicity including type, grade, dates of onset and resolution, interventions to manage toxicity, and sequelae. * Information regarding pregnancy or conception during imatinib therapy for both male and female patients, including dates of pregnancy, outcome of pregnancy, interventions during pregnancy, management of CML during pregnancy, complications during pregnancy, status of the product, condition of the born child, and information on lactation. * This information will be reviewed from the documents received as part of the routine communication with the local oncologist or from the studies obtained at MDACC. * There will be no treatment changes or recommendations as a result of this study. This study will be strictly limited to review of charts. Patients will continue their treatment as recommended by their local oncologist and treating physician at MDACC. * These results will be compared to similar patients treated with imatinib in the context of clinical trials both from published literature and from other studies conducted at MDACC. The efficacy, safety and prognostic markers will be compared. * We will review data from July 1, 1998 to August 1, 2019. SAMPLE SIZE: Approximately 3000 charts will be reviewed.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 3000 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with any FDA-approved tyrosine kinase inhibitor (eg, imatinib, dasatinib, nilotinib) not on an MDACC clinical trial regardless of prior treatment history that has had at least one clinic visit at MDACC will be eligible. Exclusion Criteria: N/A
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.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
University of Texas MD Anderson Cancer Center
Houston, United StatesAbrir University of Texas MD Anderson Cancer Center en Google Maps