VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years
NCT ID: NCT02606825
Last Updated: 2020-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3910 participants
OBSERVATIONAL
2015-07-31
2018-02-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Registry of AML patients > 60 years
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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Locations
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Hospital General Universitario de Alicante
Alicante, , Spain
ICO-Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital General Universitari de Castelló
Castelló, , Spain
Hospital San Pedro Alcántara
Cáceres, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, , Spain
Hospital Lucus Augusti
Lugo, , Spain
CIBERONC, Instituto Carlos III
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Univeristario Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre, Complutense University, i+12, CNIO
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocío, Instituto de Biomedicina
Seville, , Spain
Hospital Clínico Universitario, INCLIVA Biomedical Research Institute
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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References
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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.
Other Identifiers
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VILMA
Identifier Type: -
Identifier Source: org_study_id
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