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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• AML
• Leukemia

• NCT number: NCT02606825
• Study type: Observational
• Source: PETHEMA Foundation
• Status: Completed
• Start date: July 2015
• Completion date: February 15, 2018