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Phase 2 Study for Metal Detoxification in AML Therapy

This study is looking at whether removing certain metals from the body can improve outcomes for people with Acute Myeloid Leukemia (AML). Researchers believe that lowering metal levels in the blood and bone marrow might help chemotherapy work better. You would receive either standard AML therapy alone or standard therapy plus metal-detoxifying medications: DMSA (taken by mouth), Ca-EDTA (given intravenously, or by IV), Magnesium Sulfate (given by IV), and a Multivitamin (taken by mouth). The study will compare how well these two groups do, looking at safety, how long people live without the disease coming back, and overall survival. To join, you must be 18 or older and have newly diagnosed or untreated intermediate-risk, high-risk, or secondary AML.

Study design
This is a Phase 2 interventional study comparing two groups of participants, with a planned enrollment of 140 people.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be monitored through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06811233

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~140 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:DMSACa-EDTAMagnesium SulfateMultivitamin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Acute Myeloid Leukemia (AML)

Explore related trials

Acute Myeloid LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveMyeloproliferative Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Maro Ohanian, DO
[email protected]
(713) 792-2631
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 \[t(8;21) or inv(16)\]
Secondary AML evolved from prior untreated MDS, myeloproliferative neoplasm (MPN), or Aplastic Anemia
Therapy-related AML (t-AML)
AML evolved after prior MDS, MPN, or Aplastic Anemia after prior therapy for those myeloid bone marrow disorders
Secondary AML, including blast phase of MPN (MPN-BP) \[also, including CML in blast phase (BP of CML) after prior hematologic myeloid bone marrow disease (MDS, MPN, Aplastic Anemia, CML) (patients may have received treatment for their prior hematologic disorder for their previous bone marrow disorder) . Newly diagnosed (or untreated) myeloid blast phase of MPN (including myeloid blast phase of CML)/Ph+AML.150 4. Patients can enroll on this study after start of non-investigational induction therapy but must be within first 2 cycles of front-line therapy, as long as not in a complete remission. 5. Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) are allowed/Ph+ AML are allowed. 6. Eastern Cooperative Oncology Group (ECOG) performance status of . 2 7. Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):
Serum creatinine.2.0 mg/dL
Total Bilirubin . 2.0 x Upper limit of normal (ULN) unless the patient has Gilbert fs.
AST (SGOT) and/or ALT (SGPT) . 2.0 x ULN 8. Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within 14 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partners vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of childbearing potential. 9. Extramedullary disease is allowed if it can be measured and followed for response.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0