S095031-178

Section NCT
Category Hematological neoplasms
Subcategory Myelodysplastic Syndrome (MDS)
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 }
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Short name 910-000000064