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

ConditionsAcute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Myelogenous Leukemia, BCR-ABL1 Positive High Risk Myelodysplastic Syndrome Myelodysplastic Syndrome Myelodysplastic/Myeloproliferative Neoplasm Myeloproliferative Neoplasm Recurrent Acute Myeloid Leukemia Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive Recurrent Myelodysplastic Syndrome Recurrent Myelodysplastic/Myeloproliferative Neoplasm Refractory Acute Myeloid Leukemia Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive Refractory Myelodysplastic Syndrome Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndrome Very High Risk Myelodysplastic Syndrome

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age1+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

Edetate Calcium Disodium
Multivitamin
Succimer

Treatment groups

58 Participants

are divided into 2 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov