Evaluating Quality of Life in Patients with Low Risk Myelodysplastic Syndromes Receiving Blood Transfusions

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

This study is trying to see how blood transfusions affect the quality of life for people with low risk myelodysplastic syndromes who need these transfusions.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Oviedo, Principality of Asturias)
• Trial ID: NCT06614595 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess changes in quality of life (QoL) among patients diagnosed with low risk myelodysplastic syndromes (MDS) who are dependent on red blood cell transfusions. Participants will undergo evaluations of their cardiorespiratory function using an ergospirometer before transfusions, and their QoL will be measured using the QUALMS instrument developed by Dr. Gregory Abel. Additionally, cardiac biomarkers and plasma cytokines will be analyzed before and after transfusions to correlate with changes in QoL.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of low risk myelodysplastic syndrome who are dependent on red blood cell transfusions.

Not a fit: Patients undergoing treatments such as azacitidine or those with high or very high risk categories of MDS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into improving the quality of life for patients with low risk MDS who require regular blood transfusions.

How similar studies have performed: While this study focuses on a specific patient population, similar observational studies have shown success in evaluating quality of life in transfusion-dependent patients.

Eligibility criteria

Subjects must meet all of the following inclusion criteria:

1. They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.
2. Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.
3. Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.
4. Very low, low or intermediate IPSS-R risk category.
5. 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.
6. ECOG 0-3.

Exclusion criteria

1. Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.
2. High or very high IPSS-R risk category.
3. 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
4. Subjects with a score on the New York Heart Association Scale IV.
5. 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.
6. Subject with known clinically significant anaemia due to iron, vitamin B12 or folate deficiencies or autoimmune or hereditary haemolytic anaemia or uncontrolled hypothyroidism or known clinically significant haemorrhage or sequestration or subject with drug induced anaemia.
7. New onset or uncontrolled seizures.
8. Subjects with uncontrolled systemic fungal, bacterial or viral infections (defined as ongoing signs or symptoms related to the infection without improvement despite appropriate antibiotics or antimicrobial therapy).
9. Pregnant or breastfeeding women.
10. The subject has any condition, including the presence of laboratory abnormalities that would place the subject at unacceptable risk if he/she were to participate in the study.
11. The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data.

Where this trial is running

Oviedo, Principality of Asturias

• Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (RECRUITING)

Study contacts

• Study coordinator: Teresa Bernal del Castillo

Conditions: Low Risk Myelodysplastic Syndromes, Myelodysplastic Syndromes, Red blood cell transfusion, Quality of life