S095031-178
Research type
Research Study
Full title
A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) monotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study)
IRAS ID
1010694
Contact name
Emma Dixon
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier (I.R.I.S.)
Research summary
A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib monotherapy (IVO) and azacitidine monotherapy (AZA) in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an IDH1 mutation (PyramIDH study). Once they have consented to take part, treatment-naive patients will undergo a 28 day screening period before being randomised to receive either oral ivosidenib daily, or azacitidine, given as either an injection or infusion for up to 19 treatment cycles for up to 3-4 years, each cycle lasting 28 days. Patients will visit the research site weekly for as long as they are in receipt of study treatment and during that time will undergo a variety of assessments including safety observations as well as bone marrow analyses, study specific blood tests and Quality of Life questionnaires. The objective of the study is to compare complete and partial response rates between the two treatment arms.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0344
Date of REC Opinion
17 Dec 2024
REC opinion
Further Information Favourable Opinion