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
2 other identifiers
interventional
58
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
March 2, 2026
February 1, 2026
8.6 years
August 10, 2018
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
At 30 days post-treatment
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).
Up to the end of cycle 1 (each cycle is 28 days)
Study Arms (2)
Cohort I (edetate calcium disodium, multivitamin)
EXPERIMENTALDuring standard of care chemotherapy, patients receive edetate calcium disodium IV daily over 30 minutes for 4 doses for each cycle. Treatment continues for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive up to 12 multivitamin capsules PO daily while on study. DOSE EXPANSION: During standard of care chemotherapy, patients receive edetate calcium disodium IV daily over 30 minutes for 4 doses for each cycle. DMSA daily for 21 days. Multivitamin capsules daily while on study. Patients will receive treatment for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Cohort II (succimer, multivitamin)
EXPERIMENTALDuring standard of care chemotherapy, patients receive succimer PO daily for 8 or 21 days of each cycle beginning day 1. Treatment continues for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive up to 12 multivitamin capsules PO daily while on study. DOSE EXPANSION: During standard of care chemotherapy, patients receive edetate calcium disodium IV daily over 30 minutes for 4 doses for each cycle. DMSA daily for 21 days. Multivitamin capsules daily while on study. Patients will receive treatment for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO
Given PO
Eligibility Criteria
You may qualify if:
- 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.
- +12 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maro Ohanian
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2018
First Posted
August 15, 2018
Study Start
October 11, 2018
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
March 2, 2026
Record last verified: 2026-02