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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT03435341

Collaborator

(none)

151

Enrollment

Locations

Actual Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

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).
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 Design

Study Type:

Observational

Actual Enrollment :

151 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 :

Feb 28, 2018

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The median survival time in adult patients over 60 with AML diagnosis [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

Overall Survival [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 [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 [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 [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 [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 [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 [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Jerez	Jerez	Andalucía/Cádiz	Spain	11404
2	Hospital Virgen de las Nieves	Granada	Andalucía/Granada	Spain	18014
3	Hospital Carlos Haya	Málaga	Andalucía/Málaga	Spain	29010
4	Hospital Virgen del Rocio	Sevilla	Andalucía/Sevilla	Spain	41013
5	Hospital Universitario Nuestra Señora de Valme	Sevilla	Andalucía/Sevilla	Spain	41014
6	Hospital Univ. Reina Sofia	Córdoba	Andalucía	Spain	14004
7	Hospital Universitario Virgen Macarena	Sevilla	Andalucía	Spain	41009
8	Hospital Clínico Lozano Blesa	Zaragoza	Aragón	Spain	50009
9	Hospital Universitario Cabueñes	Gijón	Asturias	Spain	33394
10	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
11	Hospital Son Espases	Palma de Mallorca	Baleares	Spain	07120
12	Hospital Universitario de Burgos	Burgos	Castilla-León	Spain	09006
13	Hospital de León	León	Castilla-León	Spain	24071
14	Complejo Hospitalario de Salamanca	Salamanca	Castilla-León	Spain	37120
15	Clínico de Valladolid	Valladolid	Castilla-León	Spain	47003
16	Hospital del Mar	Barcelona	Cataluña	Spain	08003
17	Hospital Arnau de Vilanova Lleida	Lleida	Cataluña	Spain	25198
18	Hospital de Althaia (H. Sant Juan de Deu de Manresa)	Manresa, Barcelona	Cataluña	Spain	08243
19	Hospital Infanta leonor	Madrid	Comunidad Madrid	Spain	28031
20	Hospital General Alicante	Alicante	Comunidad Valenciana	Spain	03010
21	Hospital General Universitario de Valencia	Valencia	Comunidad Valenciana	Spain	46014
22	Hospital Infanta Cristina	Badajoz	Extremadura	Spain	06080
23	Complejo Hospitalario Universitario de A Coruña	La Coruña	Galicia	Spain	15006
24	Complejo Hospitalario Universitario de Orense	Ourense	Galicia	Spain	32005
25	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Islas Canarias	Spain	35010
26	Hospital Nuestra Señora de Candelaria	Santa Cruz de Tenerife	Islas Canarias	Spain	38010
27	Hospital Universitario Canarias	Santa Cruz de Tenerife	Islas Canarias	Spain	38320
28	Hospital Santa Lucía	Cartagena, Murcia	Murcia	Spain	30202
29	Complejo Hospitalario de Navarra	Pamplona, Navarra	Navarra	Spain	31008
30	Hospital de Basurto	Bilbao, Vizcaya	País Vasco	Spain	48013
31	Hospital Universitario de Donostia	San Sebastián, Guipúzcoa	País Vasco	Spain	20014
32	Hospital de Txagorritxu	Vitoria	País Vasco	Spain	01009
33	Hospital Universitario La Princesa	Madrid		Spain	28006
34	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
35	Fundación Jiménez Díaz	Madrid		Spain	28040
36	Hospital Clínico San Carlos	Madrid		Spain	28040
37	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
38	Hospital Universitario La Paz	Madrid		Spain	28046
39	Hospital de Fuenlabrada	Madrid		Spain	28222
40	Hospital de Getafe	Madrid		Spain	28905