Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Collecte de données
Données issues de dossiers médicaux ou de données préexistantes - RétrospectiveMaladies de la moelle osseuse+10
+ Maladie chronique
+ Maladies Hématologiques
Cas témoins
Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.Résumé
Date de début de l'étude : 8 juin 2005
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.3000 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas témoins
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
University of Texas MD Anderson Cancer Center
Houston, United StatesOuvrir University of Texas MD Anderson Cancer Center dans Google Maps