Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Data Collection
Collected from past medical records and data - RetrospectiveBone Marrow Diseases+10
+ Chronic Disease
+ Hematologic Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: June 8, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas MD Anderson Cancer Center
Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps