24
Participants
Start Date
July 22, 2025
Primary Completion Date
July 31, 2026
Study Completion Date
July 31, 2027
Arsenic Trioxide (ATO)
"Study treatment: oral Arsenic 5d/7 for 21 days over a 28-day cycle, three doses tested (0.10 mg/kg, 0.15 mg/kg and 0.20 mg/kg).~Dose escalation cohort to determine the dose limiting toxicity according to a BOIN (Bayesian optimal interval) scheme, 9 patients will be treated at each dose.~An expansion cohort at the selected dose will be conducted with 6 patients.~Tolerability will be assessed after one treatment cycle. Response will be assessed after 3 cycles of treatment. Responders may continue study treatment until progression or limiting toxicity. Limiting toxicity is defined as any grade III/IV extra-hematological toxicity or grade IV hematological toxicity lasting more than 25 days."
RECRUITING
Hôpital Saint Louis - Service Hématologie séniors, Paris
NOT_YET_RECRUITING
Institut Gustave Roussy - Service d'hématologie, Villejuif
NOT_YET_RECRUITING
CHU de Nice - Hôpital l'Archet - Service d'hématologie clinique, Nice
Groupe Francophone des Myelodysplasies
OTHER