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

NCT06811233 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2024-1369NCI-2025-00860CDMRP-TX230317
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

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

  Through study completion; an average of 1 year

Study Arms (1)

Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy

EXPERIMENTAL

Participants treatment will be administered on either an inpatient or outpatient basis

Drug: DMSA; Drug: Ca-EDTA; Drug: Magnesium Sulfate; Drug: Multivitamin

Interventions

DMSA DRUG

Given PO

Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy

Ca-EDTA DRUG

Given by IV

Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy

Magnesium Sulfate DRUG

Given by infusion

Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy

Multivitamin DRUG

Given PO

Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form for participants 18 years or older, unless LAR signs where applicable along with any required verbal assents if patients can provide assent.
• Age 18 years or older at the time of signing the informed consent form.
• Diagnosis of Any of the Following:
• 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 types include:
• 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
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of . 2
• Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):
• Serum creatinine.2.0 mg/dL

You may not qualify if:

• Nursing and pregnant individuals. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform their treating physician immediately.
• Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk.
• Acute Promyelocytic leukemia (APL)
• Prior venetoclax failure

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Succimer; Magnesium Sulfate; Geritol

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids

Study Officials

• Maro Ohanian, DO

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maro Ohanian, DO

CONTACT

(713) 792-2631; mohanian@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)