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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether removing metals from the body can improve treatment outcomes for individuals with certain types of acute myeloid leukemia (AML), such as intermediate-risk or high-risk AML. The study incorporates metal detoxification using two chelating agents, Ca-EDTA and DMSA, into standard AML therapy to determine if it better controls the disease or enhances chemotherapy's effectiveness. Suitable candidates include those newly diagnosed with intermediate or high-risk AML, or secondary AML, who are not in complete remission after initial treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining the safety of combining two treatments, Ca-EDTA (calcium disodium edetate) and DMSA (dimercaptosuccinic acid), for patients with acute myeloid leukemia (AML). Earlier studies have focused on understanding the side effects and determining the optimal dose for patients.

Ca-EDTA and DMSA typically remove metals from the body, a process known as chelation. Past research indicates that patients generally tolerate these treatments well. However, like any treatment, side effects can occur. Common side effects include stomach issues, such as nausea or an upset stomach, and mild skin reactions.

This trial is in a middle stage, indicating that earlier tests showed it was safe enough to involve more patients. This suggests the treatment is likely well-tolerated, but ongoing research will provide more detailed safety information. Potential participants should discuss any concerns with their healthcare provider to understand what this might mean for them personally.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using Ca-EDTA and DMSA for treating acute myeloid leukemia (AML) because they introduce a novel approach: metal detoxification. Unlike standard treatments like chemotherapy, which target cancer cells directly, these agents work by removing toxic heavy metals from the body, potentially reducing the stress on healthy cells and improving overall outcomes. This method could offer a complementary angle to existing therapies, aiming to enhance their effectiveness and minimize side effects.

What evidence suggests that metal detoxification might be an effective treatment for AML?

Studies suggest that certain treatments to remove metals from the body might improve outcomes for patients with acute myeloid leukemia (AML). In this trial, participants will receive a combination of Ca-EDTA and DMSA alongside standard AML therapy. These treatments aim to lower specific metal levels in the blood and bone marrow. Researchers believe that reducing these metal levels might enhance the body's response to chemotherapy. Although no direct evidence yet shows this treatment specifically benefits AML, these substances have successfully removed metals like lead from the body. This detoxification could potentially help control the disease or enhance the effectiveness of standard AML treatments.12345

Who Is on the Research Team?

MO

Maro Ohanian, DO

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Metal Detoxification with DMSA + Ca-EDTA with Standard AML TherapyExperimental Treatment4 Interventions

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+

Citations

Study Details | NCT06811233 | Monitoring, Detoxifying, ...To assess overall survival and event free survival in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving ...
Metal Detoxification with Ca-EDTA and DMSA ...This phase II trial tests how well giving metal detoxification with calcium disodium edetate (Ca-EDTA) and dimercaptosuccinic acid (DMSA) during standard of ...
NCT03630991 | Edetate Calcium Disodium or Succimer in ...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 ...
Monitoring, detoxifying, and rebalancing metals during ...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.
Chelation Therapy for Acute Myeloid LeukemiaThere is no direct evidence supporting the effectiveness of Edetate Calcium Disodium for treating acute myeloid leukemia, but it has been used to reduce lead ...
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