Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS

What this trial studies

Observational study to evaluate changes in quality of life (QoL) in patients diagnosed with low risk MDS who are red blood cell (abc) transfusion dependent. Changes in QoL will be correlated with patient cardiorespiratory function. Cardiac biomarkers and plasma cytokines will also be evaluated.

Conditions in scope

• Low Risk Myelodysplastic Syndromes

Interventions

• Not specified in the public record.

Who can join

All sexes · Ages 18 Years and up

Inclusion criteria

• They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.
• Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.
• Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.
• Very low, low or intermediate IPSS-R risk category.
• Subject requires are red blood cell transfusion dependent with the following criteria: requires an average of 2 to 6 units of CH on average over an 8-week period.
• ECOG 0-3.

Exclusion criteria

• Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.
• High or very high IPSS-R risk category.
• Subject diagnosed with any active neoplasm except:
• epidermoid or basal cell carcinoma,
• carcinoma in situ of the uterine cervix
• Carcinoma in situ of the breast
• Subjects with a score on the New York Heart Association Scale IV.
• Subjects with major surgery within 8 weeks prior to study inclusion. Subjects must have fully recovered from any previous surgery prior to inclusion in the study.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2024-09-20
• Primary completion: 2025-12-20
• Last update posted: 2024-09-27
• First posted: 2024-09-26

Sponsor & contact

Lead sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias (Other)

Collaborators: Hospital Universitario Central de Asturias

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale (We expect to obtain results in one year from the beginning of the study)
  To design a score that help to identify which patients benefit from red blood cell Transfusion in terms of QoL improvement

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