Study on Monitoring and Detoxifying Metals During Acute Myeloid Leukemia (AML) Treatment
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06811233
This clinical trial is exploring whether removing metals from the body during standard treatment can improve outcomes for patients with certain types of Acute Myeloid Leukemia (AML). The study uses two detoxifying agents, Ca-EDTA and DMSA, alongside regular therapy to see if this approach helps control the disease and enhance the response to chemotherapy.
Patient Parameters
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Program Overview
The aim of this study is to find out if detoxifying metals from the blood and bone marrow during standard treatment can help patients with intermediate-risk, high-risk, or secondary Acute Myeloid Leukemia (AML) have better outcomes. Researchers believe that reducing metal levels might help control the disease and improve how well patients respond to chemotherapy. The study will compare patients receiving metal detoxification with those receiving only standard therapy to see if there are differences in survival rates, remission rates, and overall health outcomes.
Description
This study is designed to see if removing metals from the body during standard treatment can improve survival and remission rates in patients with certain types of Acute Myeloid Leukemia (AML). The study will compare two groups: one receiving standard therapy with metal detoxification and the other receiving standard therapy alone. Researchers will look at how long patients live without the disease getting worse, how many achieve remission, and how well they tolerate the treatment. The study will also monitor metal levels in the blood and bone marrow to see if detoxification is effective. Participants will be closely monitored for any side effects and overall health outcomes.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and able to understand and sign a consent form.
- Diagnosed with specific types of AML, including newly diagnosed or untreated AML, or Myeloproliferative Neoplasm in Myeloid Blast Phase (MPN-BP).
- Can join the study after starting initial therapy but must be within the first two cycles and not in complete remission.
- Have a performance status score of 2 or less, indicating they are able to carry out light work.
- Must have certain lab test results within specified ranges, unless affected by leukemia.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception. Men must agree to use a condom if their partner is of childbearing potential.
- Extramedullary disease is allowed if it can be measured and monitored.
Exclusion Criteria
- Pregnant or nursing individuals.
- Have uncontrolled illnesses such as active infections, heart failure, or psychiatric conditions that could interfere with the study.
- Diagnosed with Acute Promyelocytic Leukemia (APL).
- Have previously failed treatment with venetoclax.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | 77030 | Houston | Texas |
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