Actively Recruiting
Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)
Led by Groupe Francophone des Myelodysplasies · Updated on 2025-07-31
24
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Myelodysplastic Syndrome according to WHO 2022 classification
- Age 18 years or older
- Low-risk MDS based on Revised International Prognostic Scoring System (very low, low, intermediate)
- Failed or relapsed after Erythropoiesis Stimulating Agents (ESA) or ineligible for ESA
- Failed or relapsed after Luspatercept if sideroblastic MDS
- Failed or relapsed after Lenalidomide if del(5q) MDS
- Transfusion dependence with at least 3 red blood cell transfusions within 16 weeks and at least 2 transfusion episodes
- Not eligible for another clinical trial
- Adequate kidney function with creatinine below 1.5 times upper limit of normal and creatinine clearance at least 40 mL/min
- Adequate liver function with bilirubin and transaminases less than 1.5 times upper limit of normal
- Not refractory to platelet transfusions
- Written informed consent provided
- Able to follow study visit schedule and comply with protocol
- Performance status 0-2 at screening
- Female of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and after study
- Male participants must agree to use condoms during and after study
You will not qualify if you...
- Severe infection or any uncontrolled severe condition
- Uncontrolled hypertension
- Significant heart disease (NYHA Class III or IV) or heart attack within last 6 months
- QTcF interval greater than 460 milliseconds
- Use of investigational agents within 30 days or anticancer therapy (excluding hydroxyurea) within 2 weeks before study
- Use of Erythropoiesis Stimulating Agents within 4 weeks before study
- Active cancer or cancer within the last year except basal cell carcinoma or carcinoma in situ of cervix or breast
- Currently enrolled in another investigational drug trial
- Known HIV infection or active hepatitis B or C
- Women who are pregnant, could become pregnant, or breastfeeding
- Medical or psychiatric conditions preventing informed consent
- Eligible for allogeneic stem cell transplantation
- No affiliation with a health insurance system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
CHU de Nice - Hôpital l'Archet - Service d'hématologie clinique
Nice, France, 06200
Not Yet Recruiting
2
Hôpital Saint Louis - Service Hématologie séniors
Paris, France, 75010
Actively Recruiting
3
Institut Gustave Roussy - Service d'hématologie
Villejuif, France, 94805
Not Yet Recruiting
Research Team
T
Thomas CLUZEAU, MD/PhD
CONTACT
J
Jean Baptiste MICOL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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