Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
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)
Description for laymen
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)
JSON Data
{
"short_title": "S095031-178",
"data_mode": "910",
"data_mode_number": "000000064",
"official_title": null,
"accrual_state": "running",
"therapeutic_value": "not_applicable",
"therapieansatz_value": "not_applicable",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": null,
"eudract_number": "2023-510155-37-00",
"general_contact_email": "sal-aml-register@ukdd.de",
"general_contact_phone": "+49 351-45818380",
"hauptpruefer_dd_name": null,
"description_laie_de": "Eine multizentrische, offene, randomisierte, nicht vergleichende Studie der Phase 3 mit zwei\nArmen zur Monotherapie mit Ivosidenib (IVO) und Azacitidin (AZA) \nbei erwachsenen Patienten mit hypomethylierenden Mitteln (HMA) naiven \nmyelodysplastischen Syndromen (MDS) mit einer Isocitratdehydrogenase-1 \n(IDH1)-Mutation (PyramIDH-Studie)",
"description_laie_en": "A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) \r\nmonotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study)",
"description_expert_de": "Eine multizentrische, offene, randomisierte, nicht vergleichende Studie der Phase 3 mit zwei\nArmen zur Monotherapie mit Ivosidenib (IVO) und Azacitidin (AZA) \nbei erwachsenen Patienten mit hypomethylierenden Mitteln (HMA) naiven \nmyelodysplastischen Syndromen (MDS) mit einer Isocitratdehydrogenase-1 \n(IDH1)-Mutation (PyramIDH-Studie)",
"description_expert_en": "A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) \r\nmonotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study)",
"rechtsgrundlage_value": null,
"phase_amg_value": null,
"main_cat_id": 4,
"sub_cat_id": 25
}
