Clinical trial NCT02606825: VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years
Official title: VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years or Not Candidates for Intensive Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AML
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 3910
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥60 years, diagnosed of AML or not candidates to intensive chemotherapy

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.

Detailed description: Approximately in 6 months, collect and review the retrospective data.

During this period, and in order to ensure an excellent quality of the collected data, perform constant monitoring and real-time data received in 2 phases:

1. Monitoring "in situ" in the focal point: once the information is received before shall enter in the database, will be reviewed each case report data (CRD) for screening for inconsistencies and issue unresolved issues (queries) to sender data center. After entering the information in the database is carry out and resolve those queries that have arisen after consultation Data tables in order to locate inconsistencies or unavailable fields.
2. Telephone Monitoring: data shall be verified through telephone consultations all centers to verify and update recruitment and monitoring patients . To ensure the completion, accuracy and data quality is monitored by telephone at least 30% of registered patients.

   * Final statistical analysis (approximately 8 months from baseline).
   * Publication of results.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Response Rate
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: ICO-Hospital Germans Trias i Pujol
city: Castelló
country: Spain
facility: Hospital General Universitari de Castelló
city: Cáceres
country: Spain
facility: Hospital San Pedro Alcántara
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: CIBERONC, Instituto Carlos III
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Univeristario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre, Complutense University, i+12, CNIO
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío, Instituto de Biomedicina
city: Valencia
country: Spain
facility: Hospital Clínico Universitario, INCLIVA Biomedical Research Institute
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References:
citation: 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.