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

ConditionsAcute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Myelogenous Leukemia, BCR-ABL1 PositiveHigh Risk Myelodysplastic SyndromeMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMyeloproliferative NeoplasmRecurrent Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecurrent Myelodysplastic SyndromeRecurrent Myelodysplastic/Myeloproliferative NeoplasmRefractory Acute Myeloid LeukemiaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Myelodysplastic SyndromeSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromeVery 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Edetate Calcium Disodium

    Drug

    Given IV

  • Multivitamin

    Dietary supplement

    Given PO

  • Succimer

    Drug

    Given PO

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Cohort I (edetate calcium disodium, multivitamin)Experimental treatment 2 interventions
Group B: Cohort II (succimer, multivitamin)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Safety data of the patients will be summarized using descriptive statistics such as mean, standard deviation, median and range. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by category, severity and frequency.

Time frame
At 30 days post-treatment
2

Maximum tolerated doses (MTD) of edetate calcium disodium (Ca-EDTA) and succimer (DMSA) (Phase 1 dose escalation)

The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle dose-limiting toxicity (DLT).

Time frame
Up to the end of cycle 1 (each cycle is 28 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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