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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02606825
Enrollment
3910
Registered
2015-11-17
Start date
2015-07-31
Completion date
2018-02-15
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

Brief 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.

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.

Interventions

OTHERRegistry of AML patients > 60 years

Sponsors

PETHEMA Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Response Rate8 monthsThe 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026