Could removing metals boost chemo in leukemia?
NCT ID NCT06811233
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether adding metal detoxification drugs (DMSA and Ca-EDTA) to standard therapy can improve outcomes for adults with intermediate- to high-risk acute myeloid leukemia (AML). Researchers believe lowering metal levels in blood and bone marrow may help control the disease or boost chemotherapy response. About 140 participants will be randomly assigned to receive detox therapy or standard care alone, with safety and side effects closely monitored.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DMSA, Ca-EDTA, magnesium sulfate, and multivitamin
- What this could lead to
- If it works, this could point toward a way to improve chemotherapy response and disease control in AML by reducing metal levels in the body.
- What could go wrong
- This is an early phase 2 trial with only 140 participants, so results may not apply to all AML patients. The detox approach is experimental and may not improve outcomes or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can an Anti-Inflammation drug make AML chemotherapy work better?
- Blood cancer registry tracks thousands to map disease course
- Can a new drug trio overcome venetoclax resistance in leukemia?