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 range1 Year
SexALL
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 …
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)