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New treatment option for Low-risk Myelodysplastic Syndromes
Official title Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)
ClinicalTrials.gov ID: NCT06670222
What this study is testing
What is Arsenic Trioxide (ATO)?
Arsenic Trioxide (ATO) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for low-risk myelodysplastic syndromes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all the following criteria to participate in the study:
- 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...
- non-sideroblastic who failed to achieved a response or who subsequently relapse after Erythropoiesis Stimulating Agents (ESA) (at Epoetin alfa...
You likely can't join if
- Any patient meeting one of the following criteria cannot be included in the study:
- 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
- Use of investigational agents within 30 days or any anticancer therapy (including IMiD (Immunomodulatory treatments)) within 2 weeks before the study...
See the full eligibility criteria
- Patients must meet all the following criteria to participate in the study:
- 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):
- 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...
- 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...
- del (5q) who failed to achieved a response or who subsequently relapse after ESA (at Epoetin alfa 60000IU or equivalent over at least 12 weeks) and who failed to achieved a response or who subsequently relapse after...
- 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
- Written consent
- Patient must understand and voluntarily sign informed consent form
- Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements
- Performance status 0-2 at the time of screening
- A FCBP (female of childbearing potential) for this study was defined as a sexually mature woman who: (1) had not undergone a hysterectomy or bilateral oophorectomy; or (2) had not been naturally postmenopausal...
- Have had 2 negative pregnancy tests as verified by the investigator prior to starting IP (unless the screening pregnancy test was done within 72 hours of Cycle 1 Day 1). She must have had agreed to ongoing a monthly...
- If sexually active, agreed to have used, and been able to comply with, highly effective contraception\ \ without interruption, 5 weeks prior to starting treatment, during treatment (including dose interruptions), and...
- Highly effective contraception was defined in this protocol as the following (information also appeared in the Informed Consent Form): Hormonal contraception (eg, birth control pills, injection, implant, transdermal...
- Male people must: Have agreed to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane), during sexual contact with a pregnant female or a FCBP while...
- Any patient meeting one of the following criteria cannot be included in the study:
- 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
- Use of investigational agents within 30 days or any anticancer therapy (including IMiD (Immunomodulatory treatments)) within 2 weeks before the study entry with the exception of hydroxyurea. The patient must have...
- Use of EPO within 4 weeks before the study entry
- Active cancer or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast
- Patient already enrolled in another therapeutic trial of an investigational drug
- Known Human Immunodeficiency Virus infection or active hepatitis B or C
- Women who are or could become pregnant or who are currently breastfeeding
- Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form
- Patient eligible for allogeneic stem cell transplantation
- No affiliation to a health insurance system
The study team makes the final eligibility decision.
Where it's taking place
- Nice, France
- Paris, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, France; Paris, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.