Luspatercept in long term follow-up – Clinical Trial Open to Recruitment8 Dec. 2020
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Luspatercept in long term Follow up
- SUB-TYPE OF MDS:Low risk MDS patients who have participated in other Luspatercept clinical trials
- SEVERITY OF MDS: IPSS-R Very Low, Low or Intermediate Risk MDS
- NAME OF DRUG: Luspatercept
- 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).
- 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.
- Secondary outcome:To determine the overall survival in this patient group.
- 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
- 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.
- 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.