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

NCT06811233 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

DMSA

Given PO

DRUG

Ca-EDTA

Given by IV

DRUG

Magnesium Sulfate

Given by infusion

DRUG

Multivitamin

Given PO

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Maro Ohanian, DO · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2029-08-31
Completion
2031-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811233 on ClinicalTrials.gov