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Oral arsenic (ATO) in low-risk myelodysplastic syndromes (MDS) failing Erythropoiesis Stimulating Agents and Luspatercept
EU CTIS ID: 2024-515311-22-00
What this study is testing
Part 1 (Phase I study): To determine the dose-limiting toxicity (DLT) of oral ATO Part 2 (Expansion phase): To determine the erythroid response rate (HI-E) after 12 weeks oral ATO treatment
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Myelodysplastic syndrome according to WHO 2022 classification
- 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 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
- Diabetic patients should have well-controlled diabetes with HbA1c level ≤ 7.5% prior to inclusion
- 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 (amenorrhea following cancer therapy did not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). A FCBP participating in the study must: o 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 pregnancy testing during the course of the study and after EOT. o If sexually active, agreed to have used, and been able to comply with, highly effective contraception** without interruption, 5 weeks prior to starting IP, during treatment with IP (including dose interruptions), and for 24 weeks after discontinuation of IP. **Highly effective contraception was defined in this protocol as the following (information also appeared in the ICF): Hormonal contraception (eg, birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), or a partner with a vasectomy. Male subjects 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 participating in the study, during dose interruptions, and for at least 24 weeks following IP discontinuation, even if he had undergone a successful vasectomy.
You likely can't join if
- Severe infection or any uncontrolled severe condition
- 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 HIV infection or active hepatitis B or C
- Patients with hypoxia requiring oxygen assistance
- Patients with overrisk of encephalopathy (ie: vitamin B1 deficiency)
See the full eligibility criteria
Who can join
- Myelodysplastic syndrome according to WHO 2022 classification
- 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 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
- Diabetic patients should have well-controlled diabetes with HbA1c level ≤ 7.5% prior to inclusion
- 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 (amenorrhea following cancer therapy did not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). A FCBP participating in the study must: o 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 pregnancy testing during the course of the study and after EOT. o If sexually active, agreed to have used, and been able to comply with, highly effective contraception** without interruption, 5 weeks prior to starting IP, during treatment with IP (including dose interruptions), and for 24 weeks after discontinuation of IP. **Highly effective contraception was defined in this protocol as the following (information also appeared in the ICF): Hormonal contraception (eg, birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), or a partner with a vasectomy. Male subjects 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 participating in the study, during dose interruptions, and for at least 24 weeks following IP discontinuation, even if he had undergone a successful vasectomy.
- 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
- Male subjects 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 participating in the study, during dose interruptions, and for at least 24 weeks following IP discontinuation, even if he had undergone a successful vasectomy.
- Age ≥ 18 years
- Patient with low-risk MDS according to IPSS-R classification (very low, low, intermediate): - non-sideroblastic who failed to achieved a response or who subsequently relapse after ESA (at Epoetin alfa 60000UI or equivalent over at least 12 weeks) without disease progression or ineligible to ESA (defined by EPO > 500UI/L) - 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 achieved a response or who subsequently relapse after Luspatercept - 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 Lenalidomide
- Transfusion dependence (at least 3 RBC required within a 16-week period and at least 2 transfusion episodes during this period)
- Patient not eligible for another clinical trial
What rules you out
- Severe infection or any uncontrolled severe condition
- 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 HIV infection or active hepatitis B or C
- Patients with hypoxia requiring oxygen assistance
- Patients with overrisk of encephalopathy (ie: vitamin B1 deficiency)
- Patients taking concomitant treatment known to prolong the QT interval
- Known hypersensibility to the arsenic or one excipient
- Persons not affiliated to a social security system or equivalent
- Persons deprived of liberty by judicial or administrative decision
- Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- 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
- Uncontrolled hypertension
- Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months
- QTcF > 460ms
- Use of investigational agents within 30 days or any anticancer therapy (including IMiD) within 2 weeks before the study entry with the exception of hydroxyurea. The patient must have recovered at least a grade 1 from all acute toxicity from any previous therapy. However, patients may have received Lenalidomide, hypomethylating agent, or anti-lymphocytic serum (ALS) (but not within 4 weeks before the study entry and, for ALS, within 16 weeks before the study entry).
- Use of EPO within 4 weeks before the study entry
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.