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

May 25, 2020 updated by: PETHEMA Foundation

VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years or Not Candidates for Intensive Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3910

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Badalona, Spain
        • ICO-HOSPITAL GERMANS TRIAS I PUJOL
      • Castelló, Spain
        • Hospital General Universitari de Castelló
      • Cáceres, Spain
        • Hospital San Pedro Alcántara
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia
      • Las Palmas, Spain
        • Hospital Universitario de Gran Canaria Doctor Negrín
      • Lugo, Spain
        • Hospital Lucus Augusti
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Univeristario Ramón y Cajal
      • Madrid, Spain
        • CIBERONC, Instituto Carlos III
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre, Complutense University, i+12, CNIO
      • Murcia, Spain
        • Hospital General Universitario Morales Meseguer
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocío, Instituto de Biomedicina
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Valencia, Spain
        • Hospital Clínico Universitario, INCLIVA Biomedical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VILMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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