Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 22, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
Low-risk Myelodysplastic Syndromes
Interventions
DRUG

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."

Trial Locations (3)

75010

RECRUITING

Hôpital Saint Louis - Service Hématologie séniors, Paris

94805

NOT_YET_RECRUITING

Institut Gustave Roussy - Service d'hématologie, Villejuif

06200

NOT_YET_RECRUITING

CHU de Nice - Hôpital l'Archet - Service d'hématologie clinique, Nice

All Listed Sponsors
lead

Groupe Francophone des Myelodysplasies

OTHER