NCT02606825

Brief Summary

This is a retrospective study to analyze the therapeutic results and clinical evolution all patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive, treated according to the different schemes available, including supportive care or palliative.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,910

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

October 13, 2015

Last Update Submit

May 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    The main objective of this study is to retrospectively evaluate the therapeutic results in the LMA in all patients older than 60 years or not candidates for intensive chemotherapy in different stages of the disease, regardless of the treatment received, and even if they do not have received (support or palliative treatment, exclusively

    8 months

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥60 years, diagnosed of AML or not candidates to intensive chemotherapy

You may qualify if:

  • Patients aged ≥60 years, diagnosed of AML or not candidates to intensive chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital General Universitario de Alicante

Alicante, Spain

Location

ICO-Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital General Universitari de Castelló

Castelló, Spain

Location

Hospital San Pedro Alcántara

Cáceres, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas, Spain

Location

Hospital Lucus Augusti

Lugo, Spain

Location

CIBERONC, Instituto Carlos III

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Univeristario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario 12 de Octubre, Complutense University, i+12, CNIO

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen del Rocío, Instituto de Biomedicina

Seville, Spain

Location

Hospital Clínico Universitario, INCLIVA Biomedical Research Institute

Valencia, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Location

Related Publications (1)

  • Martinez-Cuadron D, Serrano J, Gil C, Tormo M, Martinez-Sanchez P, Perez-Simon JA, Garcia-Boyero R, Rodriguez-Medina C, Lopez-Pavia M, Benavente C, Bergua J, Lavilla-Rubira E, Amigo ML, Herrera P, Alonso-Dominguez JM, Bernal T, Colorado M, Sayas MJ, Algarra L, Vidriales MB, Rodriguez-Macias G, Vives S, Perez-Encinas MM, Lopez A, Noriega V, Garcia-Fortes M, Ramos F, Rodriguez-Gutierrez JI, Costilla-Barriga L, Labrador J, Boluda B, Rodriguez-Veiga R, Martinez-Lopez J, Sanz MA, Montesinos P. Evolving treatment patterns and outcomes in older patients (>/=60 years) with AML: changing everything to change nothing? Leukemia. 2021 Jun;35(6):1571-1585. doi: 10.1038/s41375-020-01058-4. Epub 2020 Oct 19.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

November 17, 2015

Study Start

July 1, 2015

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations