Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodys… (NCT03630991) | Clinical Trial Compass
RecruitingPhase 1
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
United States58 participantsStarted 2018-10-11
Plain-language summary
This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and/or improve response to chemotherapy.
Who can participate
Age range
1 Year
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:
* Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \<18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and/or signed assent of minor must be obtained for participants \<18 years.
* Age ≥18 years at the time of signing the informed consent form.
* Age ≥1 years and \<18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR)
* Patients enrolling in the pediatric/adolescent/young adult exploratory cohort must be:
Age ≥ 1 years and \<18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form
* Diagnosis of any of the following:
* Newly diagnosed (or untreated) AML with intermediate-risk/poor-risk cytogenetics, intermediate-risk/poor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy)
* Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \[CML\])
* Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS/myeloid …
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
1
Incidence of adverse events
Timeframe: At 30 days post-treatment
2
Maximum tolerated doses (MTD) of edetate calcium disodium (Ca-EDTA) and succimer (DMSA) (Phase 1 dose escalation)
Timeframe: Up to the end of cycle 1 (each cycle is 28 days)