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

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ClinicalTrials.gov Identifier: NCT03435341
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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


Condition or disease
Leukemia, Myeloid, Acute

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
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020


Group/Cohort
Patients diagnosed with AML
The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435341


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Spain
Hospital de Jerez Recruiting
Jerez, Andalucía/Cádiz, Spain, 11404
Hospital Virgen de las Nieves Recruiting
Granada, Andalucía/Granada, Spain, 18014
Hospital Carlos Haya Recruiting
Málaga, Andalucía/Málaga, Spain, 29010
Hospital Virgen del Rocio Recruiting
Sevilla, Andalucía/Sevilla, Spain, 41013
Hospital Universitario Nuestra Señora de Valme Recruiting
Sevilla, Andalucía/Sevilla, Spain, 41014
Hospital Univ. Reina Sofia Recruiting
Córdoba, Andalucía, Spain, 14004
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Andalucía, Spain, 41009
Hospital Clínico Lozano Blesa Recruiting
Zaragoza, Aragón, Spain, 50009
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33011
Hospital Univ. de Guadalajara Withdrawn
Guadalajara, Castilla-La Mancha, Spain, 19002
Hospital Universitario de Burgos Recruiting
Burgos, Castilla-León, Spain, 09006
Hospital de León Recruiting
León, Castilla-León, Spain, 24071
Complejo Hospitalario de Salamanca Recruiting
Salamanca, Castilla-León, Spain, 37120
Clínico de Valladolid Recruiting
Valladolid, Castilla-León, Spain, 47003
Hospital del Mar Recruiting
Barcelona, Cataluña, Spain, 08003
Hospital de Granollers Withdrawn
Granollers, Barcelona, Cataluña, Spain, 08402
Hospital Arnau de Vilanova Lleida Recruiting
Lleida, Cataluña, Spain, 25198
Hospital de Althaia (H. Sant Juan de Deu de Manresa) Recruiting
Manresa, Barcelona, Cataluña, Spain, 08243
Hospital General Alicante Recruiting
Alicante, Comunidad Valenciana, Spain, 03010
Hospital General Universitario de Valencia Recruiting
Valencia, Comunidad Valenciana, Spain, 46014
Hospital Infanta Cristina Recruiting
Badajoz, Extremadura, Spain, 06080
Complejo Hospitalario Universitario de A Coruña Recruiting
La Coruña, Galicia, Spain, 15006
Complejo Hospitalario Universitario de Orense Recruiting
Ourense, Galicia, Spain, 32005
Hospital Dr. Negrín Recruiting
Las Palmas de Gran Canaria, Islas Canarias, Spain, 35010
Hospital Nuestra Señora de Candelaria Recruiting
Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
Hospital Universitario Canarias Recruiting
Santa Cruz de Tenerife, Islas Canarias, Spain, 38320
Hospital Santa Lucía Recruiting
Cartagena, Murcia, Murcia, Spain, 30202
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Navarra, Spain, 31008
Hospital de Basurto Recruiting
Bilbao, Vizcaya, País Vasco, Spain, 48013
Hospital Universitario de Donostia Recruiting
San Sebastián, Guipúzcoa, País Vasco, Spain, 20014
Hospital de Txagorritxu Recruiting
Vitoria, País Vasco, Spain, 01009
Hospital Universitario La Princesa Recruiting
Madrid, Spain, 28006
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital de Fuenlabrada Recruiting
Madrid, Spain, 28222
Hospital Universitario Puerta de Hierro Not yet recruiting
Madrid, Spain, 28222
Hospital de Getafe Recruiting
Madrid, Spain, 28905
Sponsors and Collaborators
Celgene
Investigators
Study Director: Montserrat Rafel, RML Advocacy Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03435341     History of Changes
Other Study ID Numbers: NDS-AML-001
U1111-1207-6661 ( Registry Identifier: UTN )
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Keywords provided by Celgene:
Acute Myeloid Leukemia (AML)
Observational
Standard Clinical Practice
Survival
Tolerability
Spain

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms