Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • DMSA

    Drug

    Given PO

  • Ca-EDTA

    Drug

    Given by IV

  • Magnesium Sulfate

    Drug

    Given by infusion

  • Multivitamin

    Drug

    Given PO

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Metal Detoxification with DMSA + Ca-EDTA with Standard AML TherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator