Imerge (Imetelstat) – Clinical Trial Open to Recruitment8 Dec. 2020
Research FOR Patients
-For an informed and empowered opinion-
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- SUB-TYPE OF MDS: Low risk MDS patients
- SEVERITY OF MDS: IPSS Low or Intermediate-1 risk MDS
- NAME OF DRUG: Imetelstat
- Aims and benefits: This phase 2/3 study aims to determine the effectiveness of Imetelstat in transfusion dependent low risk MDS patients who have either lost their response or not responded to erythropoiesis-stimulating agent (ESA) treatment. The study has 2 parts. Part 1 seeks to determine the effectiveness and safety of Imetelstat, looking more closely at improvement in blood counts and reduction in transfusion requirements. Part 2 is double-blind and randomised to compare the effectiveness of Imetelstat with placebo.
- Primary outcome:To determine the percentage of patients who have not required a red cell transfusion in an 8 week period.
- Secondary outcome:To determine adverse effects, red cell transfusion independence, improvement in blood counts, progression to acute myeloid leukaemia and overall survival.
- Basic inclusion criteria:
- Diagnosis of MDS with IPSS Low or Intermediate-1 risk
- Red blood cell transfusion dependent
- ECOG performance status 0, 1 or 2
- Basic exclusion criteria:
- Received and investigational drug or device within 30 days of study entry or enrolled in an investigational study
- Prior treatment with Imetelstat
- Prior treatment with a hypomethylating agent, Lenalidomide, an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry
- Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
- Nottingham University Hospitals NHS Trust
- Aberdeen Royal Infirmary
- The Leeds Teaching Hospitals NHS Trust
- Guy's Hospital, London
- Southampton University Hospital
Please read information and always discuss trial information with your own physician.