What side effects are associated with this type of intervention?

Common treatments for Myelodysplastic Syndrome (MDS) include chelation therapies, thrombopoietin mimetics, and erythropoiesis-stimulating agents (ESAs). Chelation therapies, such as Edetate Calcium Disodium or Succimer, can cause gastrointestinal symptoms and impaired kidney function. Thrombopoietin mimetics, like romiplostim, may increase the risk of progression to acute myeloid leukemia (AML) and cause bone marrow fibrosis. ESAs can increase the risk of thrombosis and may not be effective in all patients. Each treatment's side effects should be carefully weighed against its potential benefits.

What prior FDA approvals exist?

FDA-approved treatments for Myelodysplastic Syndrome (MDS) primarily include hypomethylating agents such as azacitidine and decitabine, which help to restore normal growth and differentiation of bone marrow cells. Lenalidomide is another approved drug, particularly effective in patients with a specific chromosomal abnormality (del 5q). While chelation therapy with agents like Edetate Calcium Disodium or Succimer is being studied for its potential to lower metal levels in the bone marrow and improve response to chemotherapy, it is not yet a standard FDA-approved treatment for MDS. Current standard treatments focus more on modifying the disease course and managing symptoms rather than chelation.

What other types of research exist?

Promising novel alternatives for treating Myelodysplastic Syndrome (MDS) patients include hypomethylating agents (HMAs) such as azacitidine and decitabine, which have shown comparable efficacy and are well-tolerated. Additionally, iron chelation therapy with deferasirox has demonstrated benefits in managing iron overload in MDS patients, improving event-free survival. These alternatives offer potential benefits over traditional chelation with Edetate Calcium Disodium or Succimer.

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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

Must not have

Acute Promyelocytic leukemia (APL)

Uncontrolled inter-current illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to the end of cycle 1 (each cycle is 28 days)

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial studies if medications that remove metals from the body can help patients with certain types of blood cancer respond better to chemotherapy. It focuses on patients with acute myeloid leukemia or myelodysplastic syndrome. The goal is to see if lowering metal levels can improve treatment outcomes. Iron chelation therapy has been shown to improve survival and quality of life in patients with myelodysplastic syndrome (MDS).

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Acute Promyelocytic Leukemia.

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I do not have any uncontrolled illnesses.

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I am currently pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to the end of cycle 1 (each cycle is 28 days)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~42190

Succimer

FDA approved

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Myelodysplastic Syndrome (MDS) include hypomethylating agents (HMAs) like azacitidine and decitabine, which work by inhibiting DNA methylation, thereby reactivating tumor suppressor genes and promoting normal cell differentiation. Erythropoiesis-stimulating agents (ESAs) such as erythropoietin help increase red blood cell production, addressing anemia. Iron chelation therapy, using agents like deferasirox, is crucial for managing iron overload due to frequent blood transfusions, which can cause organ damage. Chelation therapy, similar to the trial with Edetate Calcium Disodium or Succimer, helps remove excess metals from the body, potentially improving overall health and response to other treatments. These mechanisms are vital for MDS patients as they target the underlying pathophysiology, improve blood counts, and reduce complications, thereby enhancing quality of life.

Management of lower-risk myelodysplastic syndromes without del5q: current approach and future trends.