Actively Recruiting

Phase 1
Age: 1Year +
All Genders
NCT03630991

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-02

58

Participants Needed

1

Research Sites

446 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older, or their legally authorized representative, must understand the study and voluntarily sign consent
  • Patients under 18 years must have a parent or representative who understands the study and provides consent; assent from minors as appropriate
  • Patients aged 1 to under 18 years must weigh at least 8 kg at consent
  • Pediatric/adolescent/young adult cohort includes patients aged 1 to under 18 years (weight 68 kg) or 18 to 39 years
  • Diagnosis of newly diagnosed or relapsed/refractory AML, MDS, MDS/MPN, myeloid blast phase of MPN including CML, or high-risk malignancies in pediatric/adolescent/young adult group
  • Patients on approved or investigational drugs for hematologic malignancies are eligible
  • Newly diagnosed patients can enroll within the first 3 cycles of front-line therapy
  • Transformed AML from previously treated MDS or MPN allowed
  • ECOG performance status of 0 to 3 or Lansky/Karnofsky score 630 at entry
  • Laboratory tests within specified limits unless caused by leukemia or malignancy
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception; men must agree to contraception
  • Measurable extramedullary disease allowed
Not Eligible

You will not qualify if you...

  • Pregnant or nursing females
  • Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, or psychiatric/social issues limiting study compliance
  • Diagnosis of acute promyelocytic leukemia (APL)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Maro Ohanian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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