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).
Date de révision : 27/04/2026
5 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 07/12/2025
Critères :
Critères d'inclusion :
- Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to World Health Organization (WHO) criteria (5th edition): - Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%. - Low and moderate low-risk MDS per IPSS-M score must: o Have cytopenias related to MDS, defined as: <100 platelets/μL, or absolute neutrophil count (ANC) <1000/mm3, or Hgb <10g/dL AND o Have a blast count between 5-19% AND o Be eligible for HMA therapy (very low risk participants are to be excluded).
- Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation.
Critères d'exclusion :
- Received prior anticancer/disease modifying treatment for MDS (including HMA’s, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.
- > 20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
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Adresse
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Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".