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Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435341
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date February 5, 2018
First Posted Date February 19, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date February 28, 2018
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2018)
The median survival time in adult patients over 60 with AML diagnosis [ Time Frame: Up to approximately 12 months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 9, 2018)
  • Overall Survival [ Time Frame: Up to approximately 12 months ]
    The Kaplan Meier curve, with the median and the lower and upper limits of the 95% confidence interval, will be reported.
  • To describe the socio-demographic and clinical characteristics of patients [ Time Frame: Up to approximately 12 months ]
    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.
  • To describe the disease characteristics [ Time Frame: Up to approximately 12 months ]
    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.
  • To describe the front-line treatment strategies [ Time Frame: Up to approximately 12 months ]
    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.
  • To assess the HRQOL evolution over time [ Time Frame: Up to approximately 12 months ]
    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.
  • To evaluate the impact on early mortality [ Time Frame: Up to approximately 8 weeks ]
    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.
  • To evaluate the prognostic impact on overall survival [ Time Frame: Up to approximately 12 months ]
    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.
  • To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML. [ Time Frame: Up to approximately 12 months ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
Official Title Prospective Observational Study on Overall Survival and Quality of Life in Patients Older Than 60 Years With Acute Myeloid Leukemia Diagnosis in Spain, Treated According to Standard Clinical Practice
Brief Summary

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

Detailed Description

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:

  1. Recruitment period: One year of recruitment period, data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
  2. Follow-up period: data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

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.

Condition Leukemia, Myeloid, Acute
Intervention Not Provided
Study Groups/Cohorts Patients diagnosed with AML
The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 14, 2020)
151
Original Estimated Enrollment
 (submitted: February 9, 2018)
150
Estimated Study Completion Date October 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient of both sexes, aged 65 years and older.
  • Any race, nationality or socioeconomic status.
  • AML (defined according to WHO 2016 criteria de novo, with previous hematological history or secondary.
  • Diagnosis date later than 1st November 2017 and later than each center activation date.
  • Patients on first line treatment with any therapeutic strategy (intensive, attenuated or palliative).
  • Having given informed consent prior to start the data collection.

Exclusion Criteria:

  • Inability to understand the informed consent form.
  • AML previously treated (with or without HSCT).
  • Acute promyelocytic leukemia.
  • Participation in a clinical trial that includes first-line treatment for AML.
  • Do not grant consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03435341
Other Study ID Numbers NDS-AML-001
U1111-1207-6661 ( Registry Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Montserrat Rafel, RML Advocacy Celgene
PRS Account Celgene
Verification Date January 2020