Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)
ConditionLow-risk Myelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Francophone des Myelodysplasies
About this trial
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
Qualifiers
Myelodysplastic syndrome according to WHO (World Health Organization) 2022 classification
Age ≥ 18 years
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
Disqualifiers
Severe infection or any uncontrolled severe condition
Uncontrolled hypertension
Significant cardiac disease - NYHA (New York Heart Association) Class III or IV or having suffered a myocardial infarction in the last 6 months
QTcF (Fridericia's corrected QT interval) > 460ms
Trial design
Treatments tested in this trial
- Arsenic Trioxide (ATO)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov