RecruitingPhase 1

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

France24 participantsStarted 2025-07-22

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Myelodysplastic syndrome according to WHO (World Health Organization) 2022 classification
. Age ≥ 18 years
. Patient with low-risk Myelodysplastic Syndromes according to Revised International Prognostic Scoring System (IPSS-R) classification (very low, low, intermediate):
. Transfusion dependence (at least 3 RBC (Red Blood Cell) within a 16-week period and at least 2 transfusion episodes during this period)
. Patient not eligible for another clinical trial
. Adequate renal function defined by creatinine level less than 1.5 times the upper limit of normal and creatinine clearance ≥ 40mL/min (according to MDRD (Modification of Diet in Renal Disease) formula)
. Adequate liver function defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal
. Patient not refractory to platelet transfusions

Exclusion criteria

. Severe infection or any uncontrolled severe condition
. Uncontrolled hypertension

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine the dose-limiting toxicity (DLT) of oral Arsenic (ATO)

Timeframe: At the end of cycle 1 (each cycle is 28 days)

Trial details

NCT IDNCT06670222

SponsorGroupe Francophone des Myelodysplasies

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-24

Contact for this trial

Thomas CLUZEAU, MD/PhD

+33 492035839 cluzeau.t@chu-nice.fr

View on ClinicalTrials.gov More Low-risk Myelodysplastic Syndromes trials