ClinicalTrials.gg
RecruitingNCT03630991Updated Sep 18, 2026

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

A Phase 1 interventional study of Edetate Calcium Disodium and Multivitamin in Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2018; still recruiting 8 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Non-randomized
Ages
1 Year and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the maximal tolerated dose (MTD) of Phase 1 in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients undergoing therapy combined with succimer (DMSA) and edetate calcium disodium (Ca-EDTA). (Phase I dose escalation)
  2. To assess the efficacy information regarding the combined therapy in terms of the overall response rate (ORR) including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete count recovery (CRi), morphologic leukemia free state (MLFS), and partial remission (PR). (Phase I expansion)

SECONDARY OBJECTIVES:

  1. To assess the complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with partial hematological recovery (CRh), partial remission (PR), hematologic improvement (HI), morphologic leukemia free state (MLFS) rates, cytogenetic response, and the 1-year overall survival (OS) in AML patients and the CR/marrow CR/hematologic improvement (HI) rate, partial remission (PR) rate and 1-year overall survival (OS) and cytogenetic response in MDS patients undergoing MDS/AML therapy combined with DMSA and Ca-EDTA.
  2. To assess overall survival and event free survival in AML and MDS patients undergoing AML and MDS therapy combined with DMSA and Ca-EDTA
  3. To assess remission duration in AML and MDS patients undergoing AML and MDS therapy combined with DMSA and Ca-EDTA.
  4. To monitor toxic and essential metal levels during AML and MDS therapy combined with DMSA and Ca-EDTA and to evaluate the reduction in metals in the bone marrow and blood of newly diagnosed AML and MDS patients undergoing metal detoxification combined with standard AML/MDS therapy.
  5. To evaluate the safety profile in AML and MDS patients undergoing AML and MDS therapy combined with DMSA and Ca-EDTA.
  6. 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. Estimate the progression rate in MDS patients.
  8. To assess other responses of interest.
  9. To compare overall survival and response in this study with historical data of patients who were treated without Ca-EDTA and DMSA.

EXPLORATORY OBJECTIVES:

  1. To correlate the degree of metal chelation with the degree of therapeutic response and minimal residual disease (MRD).
  2. To collect environmental exposure data on the environmental health assessment survey.
  3. To assess P53 folding or p53 activity before and after the first dose of Ca-EDTA chelation in MDS and AML patients, and patients with other malignancies.
  4. To study changes in cytogenetic/molecular data during treatment, as well as, protein expression data (by immunohistochemistry or proteomics), including for transcription factors/tumor suppressors (e.g. TP53 and MYC).
  5. To perform pre-clinical proof of concept studies of metals and metal chelators in a variety of AML cells and cell lines including: AML cell lines, primary hematologic malignancy cells, stromal cell lines, and patient-derived stromal cells.
  6. To explore metal chelation in pediatric, adolescent, and young adult cancer patients.
02

Conditions studied

  • Acute 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
03

In context

Leukemia, Myeloid, Acute

3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

This study's planned enrollment of 58 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 )
  • 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)
  • 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; disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment
  • Patients on non- 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.
  • (ECOG) performance status of =\< 3 or Lansky or ≥ 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 =\< 2.0 x (ULN), unless the patient has Gilbert's
  • (SGOT) and/or ALT (SGPT) =\< 2.0 x ULN
  • Women of (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 . 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

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)
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Cohort I (edetate calcium disodium, multivitamin)

    During 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.

    Drug: Edetate Calcium Disodium · Dietary Supplement: Multivitamin

  • Experimental
    Cohort II (succimer, multivitamin)

    During 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.

    Dietary Supplement: Multivitamin · Drug: Succimer

Interventions

  • Given IV

    Also known as: C10H12CaN2Na2O8, Calcium disodium edetate, Calcium Disodium Ethylenediaminetetraacetate, Calcium Disodium Versenate, Calcium EDTA, Disodium calcium ethylenediaminetetraacetate, EDTA Calcium

  • Dietary supplementMultivitamin

    Given PO

    Also known as: Geritol, Vitamin Supplements (NOS)

  • Given PO

    Also known as: Chemet, DMSA, Meso 2, 3-Dimercaptosuccinic Acid

06

What researchers measure

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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03630991
Responsible party
Sponsor
First posted
Aug 15, 2018
Start date
Oct 11, 2018
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Maro Ohanian
Contact
mohanian@mdanderson.org
713-792-2631
Maro Ohanian
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Edetic Acid · Succimer

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