Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
M.D. Anderson Cancer Center
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.
Description
Primary Objective: To compare event free survival of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone. Secondary Objectives: Compare the remission rates and overall survival rates of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnose…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDMSA
Given PO
- DrugCa-EDTA
Given by IV
- DrugMagnesium Sulfate
Given by infusion
- DrugMultivitamin
Given PO
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas