Actively Recruiting
Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
Led by M.D. Anderson Cancer Center · Updated on 2026-04-23
140
Participants Needed
1
Research Sites
329 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent if 18 years or older (or LAR signs if applicable)
- Age 18 years or older at consent
- Diagnosed with newly diagnosed or untreated intermediate-risk, high-risk, or secondary AML, or newly diagnosed MPN-BP including CML-BP
- Secondary AML types allowed include those evolved from untreated MDS, MPN, Aplastic Anemia, therapy-related AML, or post-treatment AML
- Enrollment allowed after starting induction therapy but within first 2 cycles and not in complete remission
- Treated or untreated transformed AML from prior MDS, MPN, or secondary AML allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Laboratory tests within limits unless due to leukemia: serum creatinine ≤ 2.0 mg/dL, total bilirubin ≤ 2.0 x ULN (except Gilbert's), AST and/or ALT ≤ 2.0 x ULN
- Women of childbearing potential must have negative pregnancy test within 14 days and agree to contraception or abstinence
- Men must agree not to father a child and use condom if partner is of childbearing potential
- Measurable extramedullary disease allowed
You will not qualify if you...
- Nursing or pregnant individuals
- Uncontrolled inter-current illness including active infection, symptomatic heart failure, unstable angina, or psychiatric/social issues limiting compliance or increasing risk
- Diagnosis of acute promyelocytic leukemia (APL)
- Prior failure of venetoclax treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Maro Ohanian, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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