Luspatercept in long term follow-up

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Luspatercept in long term Follow up

  1. SUB-TYPE OF MDS:Low risk MDS patients who have participated in other Luspatercept clinical trials
  2. SEVERITY OF MDS: IPSS-R Very Low, Low or Intermediate Risk MDS
  3. NAME OF DRUG: Luspatercept
  4. Aims and benefits: To determine the long term safety of Luspatercept. This is a phase 3 single arm trial that is divided into 3 phases: the Transition Phase (period prior to enrollement into the study), Treatment Phase (for patients receiving Luspatercept treatment) and Follow-up Phase (Patients are observed for up to 5 years from start of Luspatercept or 3 years from the last dose of Luspatercept).
  5. Primary outcome:To determine adverse events over the period of observation as well as the incidence of disease progression and the development of other malignancies.
  6. Secondary outcome:To determine the overall survival in this patient group.

  1. Basic inclusion criteria:
    • Has been participating in a Luspatercept trial and continues to fulfill all the requirements of the parent protocol
    • Receiving Luspatercept and continues to receive clinical benefit OR Assigned to the Follow-up Phase of the parent protocol
  2. Basic exclusion criteria:
    • One or more criteria for study discontinuation as stipulated in the parent Luspatercept protocol.
    • Any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable that would prevent the subject from participating in the study.
  3. Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
    • Aberdeen Royal Infirmary
    • The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
    • Barts Health NHS Trust - The Royal London Hospital
    • Whittington Hospital, London
    • University College London Hospitals NHS Foundation Trust - University College Hospital, London
    • Kings College Hospital, London
    • Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre
    • Kings Mill Hospital, Sutton in Ashfield

Please read information and always discuss trial information with your own physician.

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