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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06811233
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DMSA — DRUG
    Given PO
  • Ca-EDTA — DRUG
    Given by IV
  • Magnesium Sulfate — DRUG
    Given by infusion
  • Multivitamin — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
May 8, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2031

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy
    Participants treatment will be administered on either an inpatient or outpatient basis

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Maro Ohanian, DO
[email protected]
713-792-2631
Maro Ohanian, DO (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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