Search / Trial NCT06614595

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

Launched by FUNDACIÓN PARA LA INVESTIGACIÓN BIOSANITARIA DEL PRINCIPADO DE ASTURIAS · Sep 24, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Myelodysplastic Syndromes Red Blood Cell Transfusion Quality Of Life

ClinConnect Summary

This clinical trial is studying how blood transfusions affect the quality of life for patients with low-risk myelodysplastic syndromes (MDS), which is a type of blood disorder. The researchers want to understand how receiving red blood cell transfusions can change a patient’s daily life and health, and they will also look at factors like heart and lung function. The study is currently recruiting participants who are at least 18 years old, have been diagnosed with low-risk MDS, and need regular blood transfusions.

To be eligible for this trial, participants must be able to understand and agree to the study procedures. They should require an average of 2 to 6 blood transfusions over an eight-week period. However, those currently receiving certain treatments or with more severe health issues, like high-risk MDS or significant heart problems, will not be eligible. Participants can expect to be monitored for changes in their quality of life and have their heart health assessed throughout the study. This research aims to provide insights that could improve care for patients with MDS.

Gender

ALL

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.

About Fundación Para La Investigación Biosanitaria Del Principado De Asturias

The Fundación para la Investigación Biosanitaria del Principado de Asturias (FIBPA) is a prominent research organization dedicated to advancing biomedical science and improving healthcare outcomes in the Asturias region of Spain. Committed to fostering innovation through collaborative research, FIBPA supports clinical trials and translational studies that bridge laboratory discoveries with patient care. By facilitating partnerships among academic institutions, healthcare providers, and industry stakeholders, FIBPA aims to enhance the efficacy of medical interventions and contribute to the development of novel therapies tailored to the needs of diverse patient populations.

Locations

Oviedo, Asturias, Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0