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Chelation Therapy for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Maro Ohanian
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of newly diagnosed (or untreated) AML with poor-risk cytogenetics, poor-risk molecular, or secondary AML
Diagnosis of newly diagnosed (or untreated) MDS/MPN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to the end of cycle 1 (each cycle is 28 days)
Awards & highlights

Study Summary

This trial is testing a drug to see if it can lower the level of metals in the bone marrow and blood of patients with leukemia or myelodysplastic syndrome, and if it helps control the disease or improves response to chemotherapy.

Who is the study for?
This trial is for adults with newly diagnosed or untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), including high-risk cases and those that have evolved from other conditions. Participants should be in good physical condition, not pregnant, able to consent, and not on certain other clinical trials. They must also agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosing of edetate calcium disodium or succimer in patients undergoing chemotherapy for AML or MDS. These agents may reduce metal levels in the body which could help control the disease and improve chemotherapy response.See study design
What are the potential side effects?
Potential side effects include reactions related to lowering metals in the body but specific side effects are being studied as part of this trial's purpose. As with any medication, individual responses can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a new or untreated AML diagnosis with high-risk factors.
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I have been newly diagnosed with MDS/MPN and have not received treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I am currently on a standard treatment or a trial with approved drugs.
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My condition is a type of blood cancer that has returned or didn't respond to treatment.
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I have a new or untreated advanced stage of a blood disorder.
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I have been diagnosed with a severe form of MDS and haven't received treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to the end of cycle 1 (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to the end of cycle 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated doses (MTD) of edetate calcium disodium (Ca-EDTA) and succimer (DMSA) (Phase 1 dose escalation)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (succimer, multivitamin)Experimental Treatment2 Interventions
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.
Group II: Cohort I (edetate calcium disodium, multivitamin)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multivitamin
2016
Completed Phase 4
~20750
Succimer
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,307 Total Patients Enrolled
Maro OhanianPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
142 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What clinical indications is Multivitamin typically employed for?

"Multivitamins are a viable solution for toxic encephalopathy and other ailments caused by exposure to elements such as arsenic, mercury, or lead."

Answered by AI

Are there any participation vacancies in this trial?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was introduced on October 11th 2018, is currently enrolling participants. 58 people need to be recruited from 1 site for the study to move forward."

Answered by AI

Has the FDA sanctioned Multivitamin for widespread usage?

"Due to the preliminary nature of this trial, with limited data for safety and efficacy evaluation, our Power team assigned Multivitamin a score of 1."

Answered by AI

What is the cap for participants in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this medical research, which was posted for the first time on October 11th 2018, is actively recruiting patients. 58 individuals need to be enrolled from a single centre."

Answered by AI

Are there any other investigations into the efficacy of Multivitamin for therapeutic gain?

"Currently, only 1 clinical trial is actively exploring the potential of Multivitamin. This study has not reached Phase 3 yet, with most of its experiments taking place in Houston, Texas and one other location."

Answered by AI
~10 spots leftby Apr 2025