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Completed

NCT Number: NCT02606825

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

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.

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Key information

Conditions

AML

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Alicante, Alicante, Spain

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Registry of AML patients > 60 years

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2015
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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