Leukemia, Myeloid, AcuteNCT03435341
Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
An observational study of Leukemia, Myeloid, Acute, run by Celgene at 40 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- How many people
- 151 participants
- Where
- 40 sitesSpain
- Study dates
- 28 Feb 2018to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Spain40 sites
Complejo Hospitalario Universitario de A Coruña
A Coruña, Galicia, 15006
Hospital General Alicante
Alicante, Valencia, 03010
Hospital Infanta Cristina
Badajoz, Extremadura, 06080
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital de Basurto
Bilbao, Vizcaya, Basque Country, 48013
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
Hospital Santa Lucía
Cartagena, Murcia, Murcia, 30202
Hospital Univ. Reina Sofia
Córdoba, Andalusia, 14004
Hospital Universitario Cabueñes
Gijón, Principality of Asturias, 33394
Hospital Virgen de las Nieves
Granada, Andalucía/Granada, 18014
Hospital de Jerez
Jerez de la Frontera, Andalucía/Cádiz, 11404
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital de León
León, Castille and León, 24071
Hospital Arnau de Vilanova Lleida
Lleida, Catalonia, 25198
Hospital Infanta leonor
Madrid, Comunidad Madrid, 28031
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid, 28034
Fundación Jiménez Díaz
Madrid, 28040
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital de Fuenlabrada
Madrid, 28222
Hospital de Getafe
Madrid, 28905
Hospital Carlos Haya
Málaga, Andalucía/Málaga, 29010
Hospital de Althaia (H. Sant Juan de Deu de Manresa)
Manresa, Barcelona, Catalonia, 08243
Complejo Hospitalario Universitario de Orense
Ourense, Galicia, 32005
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Complejo Hospitalario de Navarra
Pamplona, Navarra, Navarre, 31008
Complejo Hospitalario de Salamanca
Salamanca, Castille and León, 37120
Hospital Universitario de Donostia
San Sebastián, Guipúzcoa, Basque Country, 20014
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Hospital Universitario Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
Hospital Virgen del Rocio
Seville, Andalucía/Sevilla, 41013
Hospital Universitario Nuestra Señora de Valme
Seville, Andalucía/Sevilla, 41014
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Clínico de Valladolid
Valladolid, Castille and León, 47003
Hospital de Txagorritxu
Vitoria-Gasteiz, Basque Country, 01009
Hospital Clínico Lozano Blesa
Zaragoza, Aragon, 50009
About this study
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
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
Read the 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.
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Acute Myeloid Leukemia (AML), Observational, Standard Clinical Practice, Survival, Tolerability, Spain
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with AML | The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 12 months
Secondary outcomes (8)
Overall Survival
The Kaplan Meier curve, with the median and the lower and upper limits of the 95% confidence interval, will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Feb 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Montserrat Rafel, RML Advocacy, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435341
- Sponsor's protocol ID
- NDS-AML-001
- Other IDs
- U1111-1207-6661
- Status last verified
- May 2021
- First submitted
- 5 Feb 2018
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03435341
- Acronym / sponsor ID
- NDS-AML-001
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Acute Myeloid Leukemia (AML), Observational, Standard Clinical Practice, Survival, Tolerability, Spain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with AML | – | –The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Overall Survival
Time frame: Up to approximately 12 months
To describe the socio-demographic and clinical characteristics of patients
Time frame: Up to approximately 12 months
To describe the disease characteristics
Time frame: Up to approximately 12 months
To describe the front-line treatment strategies
Time frame: Up to approximately 12 months
To assess the HRQOL evolution over time
Time frame: Up to approximately 12 months
To evaluate the impact on early mortality
Time frame: Up to approximately 8 weeks
To evaluate the prognostic impact on overall survival
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.
Time frame: Up to approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Rafel, RML Advocacy study director
Celgene
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute, run by Celgene at 40 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median survival time in adult patients over 60 with AML diagnosis (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.