Detoxifying metals during therapy for acute myeloid leukemia

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

This study is testing if using metal detox treatments along with standard therapy can help people with acute myeloid leukemia live longer and have better treatment results.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06811233 on ClinicalTrials.gov

What this trial studies

This clinical research focuses on evaluating the effects of metal detoxification using calcium disodium edetate (Ca-EDTA) and dimercaptosuccinic acid (DMSA) in patients undergoing standard therapy for acute myeloid leukemia (AML). The study aims to compare event-free survival, remission rates, and overall survival between patients receiving detoxification alongside standard therapy and those receiving standard therapy alone. Researchers hypothesize that reducing metal levels in the blood and bone marrow may enhance treatment responses and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or untreated secondary, intermediate, or high-risk AML or myeloproliferative neoplasm in myeloid blast phase.

Not a fit: Patients with low-risk AML or those not meeting the specific diagnostic criteria for the study may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and treatment responses for patients with high-risk forms of AML.

How similar studies have performed: While the approach of metal detoxification in AML therapy is innovative, similar studies have not been widely conducted, making this a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Age 18 years or older at the time of signing the informed consent form.
3. 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
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.

Exclusion Criteria:

1. 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.
2. 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.
3. Acute Promyelocytic leukemia (APL)
4. Prior venetoclax failure

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Maro Ohanian, DO — M.D. Anderson Cancer Center
• Study coordinator: Maro Ohanian, DO

Conditions: Acute Myeloid Leukemia