VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years

NCT ID: NCT02606825

Last Updated: 2020-05-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

3910 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-02-15

Brief Summary

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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

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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.

Conditions

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AML

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Registry of AML patients > 60 years

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PETHEMA Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

ICO-Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital General Universitari de Castelló

Castelló, , Spain

Site Status

Hospital San Pedro Alcántara

Cáceres, , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas, , Spain

Site Status

Hospital Lucus Augusti

Lugo, , Spain

Site Status

CIBERONC, Instituto Carlos III

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Univeristario Ramón y Cajal

Madrid, , Spain

Site Status

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

Madrid, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Hospital Universitario Virgen del Rocío, Instituto de Biomedicina

Seville, , Spain

Site Status

Hospital Clínico Universitario, INCLIVA Biomedical Research Institute

Valencia, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 33077867 (View on PubMed)

Other Identifiers

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VILMA

Identifier Type: -

Identifier Source: org_study_id

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