RecruitingPhase 1

Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy

Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy

Who can join

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

Age
1 Year 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

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Correlate metal and copper isotopic abundance ratios of AML and MDS patients with clinical data, conventional cytogenetics, extensive next generation sequencing (NGS) (300-gene panel), exposure survey data, and clinical outcome data, and to perform a larger analysis by pooling this data with metal/genomic/survey/outcome data obtained on 2017-0937 and PA15-0302. 7."
  • "To collect environmental exposure data on the environmental health assessment survey. 3."
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 the side effects and best dose of edetate calcium disodium or succimer during chemotherapy. These drugs may lower metal levels in blood and bone marrow and help treatment work better. It is mainly for people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), with a separate group for younger people with certain other cancers.

This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and/or improve 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, or age 1–17 and weigh at least 8 kg (about 18 pounds). The separate younger-patient group is for ages 1–39.
  • You or your legal representative must understand the study and sign a consent form. Children need consent from a parent or legal representative and must agree when required.
  • Have a qualifying blood or bone marrow cancer, such as AML, MDS, or certain related cancers. Newly diagnosed cancers must meet the study’s type or risk rules. Cancers that came back or did not respond to treatment may also qualify.
  • For the separate younger-patient group, have a high-risk cancer or cancer that came back or did not respond to treatment. This includes certain leukemias, lymphomas, and other cancers.
  • Your cancer treatment must meet the study’s rules. Newly diagnosed patients may join after starting treatment, but must be within the first 3 treatment cycles.
  • Meet the study’s daily activity and kidney and liver blood test limits. Some blood test exceptions apply if changes are caused by the cancer or by Gilbert’s syndrome, a liver condition.
  • If you can become pregnant, have a negative urine pregnancy test within 7 days and agree to avoid sex that could cause pregnancy or use highly effective birth control. Men must agree not to father a child and use condoms 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 following study rules difficult or creates an unsafe risk, as judged by the study doctor.
  • Have acute promyelocytic leukemia (APL), a type of AML.

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

Official eligibility criteria

Inclusion Criteria: * Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \<18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and/or signed assent of minor must be obtained for participants \<18 years. * Age ≥18 years at the time of signing the informed consent form. * Age ≥1 years and \<18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR) * Patients enrolling in the pediatric/adolescent/young adult exploratory cohort must be: Age ≥ 1 years and \<18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form * Diagnosis of any of the following: * Newly diagnosed (or untreated) AML with intermediate-risk/poor-risk cytogenetics, intermediate-risk/poor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy) * Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \[CML\]) * Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS/myeloid neoplasm * Newly diagnosed (or untreated) MDS/MPN (regardless of cytogenetic/molecular status) * Relapsed and/or refractory AML, MDS/myeloid neoplasm , MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML) * Patients enrolling in the childhood/adolescent/young adult exploratory cohort may have any of the following diagnoses: * High-risk or relapsed/refractory childhood, adolescent, or young adult malignancies including but not limited to high-risk or relapsed/refractory ALL or other high-risk or relapsed refractory malignancies * This includes, but is not limited to, the following: High-risk ALL/LL including T-ALL/LL, Ph-like ALL/LL, Ph+ B-ALL/LL, B-ALL/LL with CNS lymphoid leukemic involvement, testicular involvement, other extramedullary involvement by ALL/LL; ALL/LL with any of the NCI high-risk features: patients aged 10 years or older and those with a white blood cell count ≥50 × 109 per L), high-risk cytogenetics (MLL rearrangements, near haploidy \[\<30 chromosomes\], low hypodiploidy \[30-39 chromosomes\], t\[17;19\]\[q23;p13\], intrachromosomal amplification of chromosome 21), Burkitts'; Burkitt's-like, Double-Hitt; CNS involvement by any non-primary brain malignancy; Metastatic disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment * Patients on non-investigational regimens or on IND-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible. * Patients on IND studies (for hematologic malignancies) utilizing FDA approved commercially available drugs are eligible. * Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND. * Newly diagnosed MDS or AML, as well as MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy of front-line therapy. Patients with relapsed and/or refractory AML, MDS, MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML) can enroll. Newly diagnosed patients enrolling in the exploratory cohort with high-risk malignancies can enroll after the start of non-investigational therapy but must be within first 3 cycles of front-line therapy. * 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 Chronic Myeloid Leukemia (CML) are allowed. * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3 or Lansky or Karnofsky ≥ 30 at study entry; patients who are unable to walk, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy): * Serum creatinine =\< 1.5 mg/dL * Total Bilirubin =\< 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's * AST (SGOT) and/or ALT (SGPT) =\< 2.0 x ULN * Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 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, partner's 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 child bearing potential * Extramedullary disease is allowed as long as it can be measured and followed for response. Note: Patients can be considered MDS by either WHO or FAB150 criteria Note: MDS risk status assessment is based on IPSS-R and/or IPSS-M. AML risk status assessment is based on ELN and World Health Organization classification Exclusion Criteria: * Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her 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 compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk * Acute Promyelocytic leukemia (APL)

Study sites (1)

TX