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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03630991
Phase
PHASE1
Status
Recruiting
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Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Edetate Calcium Disodium — DRUG
    Given IV
  • Multivitamin — DIETARY_SUPPLEMENT
    Given PO
  • Succimer — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Oct 11, 2018
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: At 30 days post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Maro Ohanian
[email protected]
713-792-2631
Maro Ohanian (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

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By specialty
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By research site
M D Anderson Cancer Center· Houston, TX

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