RecruitingNCT06614595
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life Changes
Sponsor
Fundación para la Investigación Biosanitaria del Principado de Asturias
Enrollment
30 participants
Start Date
Sep 20, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria14
- 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.
- 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.
- New onset or uncontrolled seizures.
- 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).
- Pregnant or breastfeeding women.
- 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.
- The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06614595