Edetate Calcium Disodium or Succimer for Leukemia and Myelodysplastic Syndrome
This study is testing two drugs, edetate calcium disodium and succimer, in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are receiving chemotherapy. Researchers want to find the safest and most effective dose of these drugs. They believe edetate calcium disodium or succimer might help lower metal levels in the bone marrow and blood, which could improve how well chemotherapy works. The study aims to see if these drugs can lead to a complete remission (when signs of cancer disappear) or improve your condition. About 58 people are expected to join this study, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 58 participants and is a Phase 1 trial, focusing on finding the best dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Adverse events will be measured at 30 days post-treatment. Maximum tolerated doses will be assessed up to the end of cycle 1 (each cycle is 28 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03630991
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
Recruiting
PHASE1Ages 1+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~58 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:Edetate Calcium DisodiumMultivitaminSuccimer
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over At 30 days post-treatment
+1 more outcome measured
Conditions
NCT03630991
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Maro Ohanian · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Eligibility criteria
Inclusion
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:
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.
Exclusion
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)
What this trial measures
- Incidence of adverse eventsAt 30 days post-treatment
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.
- Maximum tolerated doses (MTD) of edetate calcium disodium (Ca-EDTA) and succimer (DMSA) (Phase 1 dose escalation)Up to the end of cycle 1 (each cycle is 28 days)
The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle dose-limiting toxicity (DLT).