About this trial
The goal of this clinical research study is to learn if metal detoxification (with calcium disodium edetate \[Ca-EDTA\] and dimercaptosuccinic acid \[DMSA\]) during standard therapy can help improve outcomes in patients with intermediate-risk, high-risk, or secondary AML compared to standard therapy alone. Researchers think lowering the level of metals found in the blood/bone marrow may help to control the disease and/or improve the response to chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand and voluntarily sign an informed consent form for participants 18 years or older, unless LAR signs where applicable along with any required verbal assents if patients can provide assent.
Age 18 years or older at the time of signing the informed consent form.
Newly diagnosed (or untreated) AML or Newly diagnosed Myeloproliferative Neoplasm in Myeloid Blast Phase (MPN-BP) [including Chronic Myeloid Leukemia in Blast Phase (CML-BP)], Ph+AML with intermediate-risk or high-risk (by ELN), or any other intermediate or high-risk AML by ELN
Secondary AML regardless of ELN risk status, however, may not have CBF [t(8;21) or inv(16)]
Disqualifiers
Nursing and pregnant individuals. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform their treating physician immediately.
Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk.
Acute Promyelocytic leukemia (APL)
Prior venetoclax failure
Trial design
Single group
Treatments tested in this trial
DMSA
DrugGiven PO
Ca-EDTA
DrugGiven by IV
Magnesium Sulfate
DrugGiven by infusion
Multivitamin
DrugGiven PO
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator