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New treatment option for Acute Myeloid Leukemia (AML)
Official title Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study
ClinicalTrials.gov ID: NCT06811233
What this study is testing
What is DMSA?
DMSA is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Understand and voluntarily sign an informed consent form for participants 18 years or older, unless LAR signs where applicable along with any...
- Age 18 years or older at the time of signing the informed consent form.
- 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...
- Secondary AML regardless of ELN risk status, however, may not have CBF [t(8;21) or inv(16)] Secondary AML types include:
You likely can't join if
- Nursing and pregnant individuals. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study...
- Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable...
- Acute Promyelocytic leukemia (APL)
- Prior venetoclax failure
See the full eligibility criteria
- 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.
- Age 18 years or older at the time of signing the informed consent form.
- 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...
- 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...
- 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.
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of . 2
- 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
- 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...
- Extramedullary disease is allowed if it can be measured and followed for response.
- 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.
- 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...
- Acute Promyelocytic leukemia (APL)
- Prior venetoclax failure
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.