Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia and Myelodysplastic Syndrome Therapy

What this Trial Is About

Researchers are evaluating the side effects and best dose of edetate calcium disodium and succimer in treating patients with acute myeloid leukemia AML or myelodysplastic syndrome MDS who are undergoing chemotherapy. These drugs may help reduce metal levels in the bone marrow and blood, potentially aiding disease control and improving response to chemotherapy. This is a phase I trial focused on dose escalation and response rates. Patients receive standard chemotherapy combined with either edetate calcium disodium or succimer. Edetate calcium disodium is given intravenously daily over 30 minutes for 4 doses per cycle, and succimer is taken orally daily for 8 or 21 days per cycle. Treatment continues for up to 6 cycles if there is no disease progression or unacceptable side effects. Participants also take multivitamin capsules daily while on the study. During the trial, participants are monitored for side effects, overall response to treatment, and metal levels in blood and bone marrow. Researchers assess remission rates, survival, cytogenetic responses, and safety. Blood tests, molecular studies, and surveys about environmental exposures are performed. The main outcomes include adverse events within 30 days after treatment and determining the maximum tolerated doses of the study drugs. The study includes long-term follow-up of up to one year and comparison with historical data.

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