Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)
Trial Parameters
Brief Summary
Phase I study with dose-escalation and expansion evaluating the safety and efficacy of oral Arsenic (ATO) in low-risk Myelodysplastic Syndromes having failed to Erythropoiesis Stimulating Agents and Luspatercept (or ineligible for the latter).
Eligibility Criteria
Inclusion criteria: Patients must meet all the following criteria to participate in the study: 1. Myelodysplastic syndrome according to WHO (World Health Organization) 2022 classification 2. Age ≥ 18 years 3. Patient with low-risk Myelodysplastic Syndromes according to Revised International Prognostic Scoring System (IPSS-R) classification (very low, low, intermediate): * non-sideroblastic who failed to achieved a response or who subsequently relapse after Erythropoiesis Stimulating Agents (ESA) (at Epoetin alfa 60000UI or equivalent over at least 12 weeks) without disease progression or ineligible to ESA (defined by Erythopoietine (EPO) \> 500UI/L) * sideroblastic who failed to achieved a response or who subsequently relapse after ESA (at Epoetin alfa 60000UI or equivalent over at least 12 weeks) or ineligible for ESA (defined by EPO \>500UI/L) and who failed to achieved a response or who subsequently relapse after Luspatercept * del (5q) who failed to achieved a response or who subse