140 Participants Needed

Metal Detoxification for Acute Myeloid Leukemia

MO
Overseen ByMaro Ohanian, DO
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of 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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the study team or your doctor.

Is the metal detoxification treatment generally safe for humans?

The safety of Ca-EDTA and DMSA (metal detoxification agents) has been studied in various contexts, and they are generally considered safe for human use when administered properly. However, specific safety data for their use in acute myeloid leukemia is not provided in the available research.12345

How does the drug Ca-EDTA, DMSA differ from other treatments for acute myeloid leukemia?

Ca-EDTA and DMSA are unique in treating acute myeloid leukemia because they focus on detoxifying heavy metals, which may impact survival rates, unlike traditional treatments that target cancer cells directly. This approach is based on research suggesting that metal levels in the body can influence leukemia outcomes.23467

Research Team

MO

Maro Ohanian, DO

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with intermediate-risk, high-risk, or secondary Acute Myeloid Leukemia (AML). Participants should be undergoing standard therapy for AML. Specific inclusion and exclusion criteria details are not provided but would typically relate to health status and prior treatments.

Inclusion Criteria

My cancer outside the bone marrow can be tracked for treatment response.
I have signed or will sign a consent form (or my legal representative has if I'm unable).
I have Secondary AML without certain genetic changes.
See 6 more

Exclusion Criteria

I have been treated with venetoclax, but it did not work for me.
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
I have been diagnosed with Acute Promyelocytic Leukemia.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metal detoxification with DMSA and Ca-EDTA during standard AML therapy

12 months
Inpatient or outpatient basis

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ca-EDTA
  • DMSA
Trial Overview The study tests if using metal detoxification agents like Ca-EDTA and DMSA during standard AML therapy can improve patient outcomes. It's a phase 2 randomized study where some patients will receive these additional treatments while others will not.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Metal Detoxification with DMSA + Ca-EDTA with Standard AML TherapyExperimental Treatment4 Interventions
Participants treatment will be administered on either an inpatient or outpatient basis

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

References

EDTA induces differentiation and suppresses proliferation of promyelocytic leukemia cell line HL-60--possible participation of zinc. [2013]
Arsenic concentration in peripheral blood is correlated with efficacy of a Traditional Chinese Medicine regimen containing realgar for the treatment of myelodysplastic syndrome. [2022]
Evaluation of arsenic species in leukocytes and granulocytes of acute promyelocytic leukemia patients treated with arsenic trioxide. [2021]
A heavy metal baseline score predicts outcome in acute myeloid leukemia. [2023]
Toxic effects of arsenic (As3+) and other metal ions on acute promyelocytic leukemia cells. [2019]
Altered serum levels of elements in acute leukemia cases in Turkey. [2017]
Arsenic speciation in urine from acute promyelocytic leukemia patients undergoing arsenic trioxide treatment. [2018]
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