RecruitingPhase 2

Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding two metal-removing drugs, Ca-EDTA and DMSA, to standard treatment helps control acute myeloid leukemia (AML), a blood cancer. It compares this treatment with standard treatment alone in adults with medium-risk, high-risk, or secondary AML, which develops after another bone marrow disease or past treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and give consent to join, or have a legally authorized person give consent when allowed.
  • Have newly diagnosed or untreated medium-risk or high-risk AML, or certain related blood cancers in a fast-growing phase.
  • Secondary AML may qualify at any risk level, but not with the gene changes called t(8;21) or inv(16). Past treatment for the earlier bone marrow disease is allowed.
  • If AML treatment has started, be within the first 2 cycles of standard first treatment and not yet in complete remission, meaning no signs of leukemia on standard tests.
  • Meet the study’s daily activity, kidney, and liver test rules. Some test exceptions apply. The listing does not clearly show the cutoff signs.
  • If able to become pregnant, have a negative pregnancy test within 14 days and agree to avoid sex with men or use a highly effective birth control method.
  • Men must agree not to father a child and to use a condom if their partner can become pregnant.
  • Cancer outside the bone marrow is allowed if it can be measured and checked for treatment response.

Who can't join

  • Be pregnant or breastfeeding.
  • Have an uncontrolled illness, such as an active infection, heart failure with symptoms, or unstable chest pain.
  • Have a mental health condition or life situation that makes study rules hard to follow or creates an unacceptable risk, as judged by the study doctor.
  • Have acute promyelocytic leukemia (APL), a type of AML.
  • Have had treatment with venetoclax fail.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX