Multivitamin for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myelodysplastic Syndrome+17 MoreMultivitamin - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Refractory Acute Myelogenous Leukemia
  • Chronic Myelogenous Leukemia (CML)
  • Acute Recurrent Myeloid Leukemia
  • Myeloproliferative Neoplasms
  • Acute Myeloid Leukemia (AML) arising from Myelodysplastic Syndrome (MDS)
  • Acute Myeloid Leukemia
  • Recurrent Myelodysplastic/Myeloproliferative Neoplasm
  • Refractory Myelodysplastic Syndromes
  • Secondary Acute Myeloid Leukemia
  • Myelodysplastic Syndrome (MDS)
  • Myelodysplastic/Myeloproliferative Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to the end of cycle 1 (each cycle is 28 days)

At 30 days post-treatment
Incidence of adverse events
Day 28
Maximum tolerated doses (MTD) of edetate calcium disodium (Ca-EDTA) and succimer (DMSA) (Phase 1 dose escalation)

Trial Safety

Trial Design

2 Treatment Groups

Cohort I (edetate calcium disodium, multivitamin)
1 of 2
Cohort II (succimer, multivitamin)
1 of 2

Experimental Treatment

58 Total Participants · 2 Treatment Groups

Primary Treatment: Multivitamin · No Placebo Group · Phase 1

Cohort I (edetate calcium disodium, multivitamin)Experimental Group · 2 Interventions: Multivitamin, Edetate Calcium Disodium · Intervention Types: DietarySupplement, Drug
Cohort II (succimer, multivitamin)Experimental Group · 2 Interventions: Multivitamin, Succimer · Intervention Types: DietarySupplement, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multivitamin
2016
Completed Phase 3
~20650
Succimer
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to the end of cycle 1 (each cycle is 28 days)

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,321 Total Patients Enrolled
Maro OhanianPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
142 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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