An observational study in Leukemia, Myeloid, Acute, sponsored by Celgene. Completed at 40 sites in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.
Sponsored by Celgene · Observational
Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a prospective cohort of patients over 60 with AML diagnosis in Spain and treated outside of clinical trials; that is, under conditions of standard clinical practice.
The study will last 24 months in total from the inclusion of the first patient until the end of the last patient's follow-up
Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:
The patient clinical history and the study´s questionnaires will be the source documents. The study will be carried out in the facilities of the Hematology and Hemotherapy Services of the participating centers, collecting the conditions of medical action according to the standard clinical practice.
Being an observational study, no intervention out of standard clinical practice will be performed. No additional diagnostic or treatment procedures will be applied for the patients.
The study population will consist of approximately 150 patients over 60 with AML diagnosis, defined according to World Health Organization (WHO) 2016 criteria (presence of blasts in the bone marrow or peripheral blood equal to or greater than 20%).
Due to the observational and descriptive nature of the present investigation, the inclusion of a control group is not considered.
Exclusion Criteria:
The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.
The median survival time in adult patients over 60 with AML diagnosis
The overall survival will be calculated, defined as the time from the diagnosis date to the death date from any reason. In patients who have not died (censored) at the time of data collection, it will be considered the available time to the last control (or last date). The overall survival will be analyzed using the Kaplan-Meier method, providing the median at 95% CI. Patients who undergo a hematopoietic transplant will be censored at that time.
Time frame: Up to approximately 12 months
Overall Survival
The Kaplan Meier curve, with the median and the lower and upper limits of the 95% confidence interval, will be reported.
Time frame: Up to approximately 12 months
To describe the socio-demographic and clinical characteristics of patients
A description of the study socio-demographic and clinical variables will be made. The distributions of absolute and relative frequencies of the qualitative variables will be reported, as well as the measures of central and dispersion tendency of the quantitative variables. A 95% CIs will be obtained for the main variables.
Time frame: Up to approximately 12 months
To describe the disease characteristics
A description of the variables that characterize the disease under study will be made. The distributions of absolute and relative frequencies of the qualitative variables will be reported, as the measures of central tendency and dispersion of the quantitative variables. A 95% CIs will be obtained for the main variables.
Time frame: Up to approximately 12 months
To describe the front-line treatment strategies
The frequency distributions for the first lines of treatment will be presented, as well as the rate distribution of the most frequent treatment sequences and their evolution. It will be reported the descriptive statistics period of the first treatment lines.
Time frame: Up to approximately 12 months
To assess the HRQOL evolution over time
Descriptive statistics will be reported for each of the five dimensions at every period of application of the EQ-5D, so as an overall lineal model of repeated measures for the VAS.
Time frame: Up to approximately 12 months
To evaluate the impact on early mortality
The t-test will be used to evaluate the impact of the initial leukocyte count on early mortality (dichotomous variable minus death or not in the first 8 weeks). The stratified analysis with the same approach will be done for treatments that achieve a sufficient sample.
Time frame: Up to approximately 8 weeks
To evaluate the prognostic impact on overall survival
A Cox regression model will be made considering the patient survival as a dependent variable and as possible factors the subjective variables (asthenia and HRQOL) at the time of diagnosis, the patient's general condition, and any other clinical variable that is evaluated as possible predictor. No more than 10 independent variables will be included in the model for theoretical reasons.
Time frame: Up to approximately 12 months
To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML.
The therapeutic approach will be collected according to the investigator clinical judgment, the score of each of the items on the Lee and GAH scales and the treatment administered tolerability assessment according to the score obtained in each scale. The weighting coefficients will be calculated using a complete multiple linear regression model and a multiple logistic regression. The optimal cut points for use as a predictive tool for treatment tolerability will be determined by using the ROC curve technique.
Time frame: Up to approximately 12 months
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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