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

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606825
• Other study ID #: VILMA
• Status: Completed
• Start date: July 2015
• Est. completion date: February 15, 2018

Study information

• Verified date: May 2020
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3910
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• AML
• Leukemia

Intervention

Other:
• Registry of AML patients > 60 years

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	ICO-Hospital Germans Trias i Pujol	Badalona
Spain	Hospital San Pedro Alcántara	Cáceres
Spain	Hospital General Universitari de Castelló	Castelló
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	Sevilla
Spain	Hospital Clínico Universitario, INCLIVA Biomedical Research Institute	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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