Sabatolimab (MBG453) – New Clinical Study for MDS Patients14 Apr. 2021
Research FOR Patients
-For an informed and empowered opinion-
All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.
- SUB-TYPE OF MDS: MDS patients and Chronic Myelomonocytic leukaemia -2 patients who require first-line treatment
- SEVERITY OF MDS: Intermediate, High or Very High Risk
- NAME OF DRUG: Sabatolimab (MBG453)
- Aims and benefits: MBG453 is an antibody that binds to a specific receptor on T-cells. In so doing, it abolishes the inhibitory effect that tumour cells have on T-cells and enhances the ability of the T-cells to destroy tumour cells. This Phase 3 trial seeks to determine the effectiveness of using MBG453 in combination with Azacitidine. It is a double-blind placebo controlled study. The main aim is to compare the overall survival with MBG453 plus Azacitidine versus placebo plus Azacitidine.
- Primary outcome: To determine overall survival.
- Secondary outcome: Assessment of the effects on quality of life, red cell transfusion-free intervals and time to disease progression.
- Basic inclusion criteria:
- Intermediate, High or Very High Risk Myelodysplastic Syndrome based on the IPSS-R OR Morphologically confirmed Chronic Myelomonocytic leukaemia -2
- Azacitidine is indicated
- Not eligible for intensive chemotherapy
- Not eligible for haemopoietic stem cell transplant
- ECOG of ≤ 2
- Basic exclusion criteria:
- Prior therapy with immune checkpoint inhibitors
- Previous first line treatment for Intermediate, High or Very High Risk Myelodysplastic Syndrome OR Chronic Myelomonocytic leukaemia -2
- Diagnosis of acute myeloid leukaemia
- Diagnosis of therapy related myeloid neoplasm
- Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
- Novartis Investigative Site Edinburgh, United Kingdom, EH4 2XU
- Novartis Investigative Site Nottingham, United Kingdom, NG5 1PB
If you think this information is relevant to you, please discuss it with your own physician