RECRUITING

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

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Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Myelogenous Leukemia, BCR-ABL1 PositiveHigh Risk Myelodysplastic SyndromeMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMyeloproliferative NeoplasmRecurrent Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecurrent Myelodysplastic SyndromeRecurrent Myelodysplastic/Myeloproliferative NeoplasmRefractory Acute Myeloid LeukemiaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Myelodysplastic SyndromeSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromeVery High Risk Myelodysplastic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy

Quick Facts

Study Start:2018-10-11
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03630991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Understand and voluntarily sign an informed consent form
  2. * Diagnosis of any of the following:
  3. * Newly diagnosed (or untreated) AML with poor-risk cytogenetics, poor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy
  4. * Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \[CML\])
  5. * Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS
  6. * Newly diagnosed (or untreated) MDS/MPN (regardless of cytogenetic/molecular status)
  7. * Relapsed and/or refractory AML, MDS, MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML) who are either salvage 1 or salvage 2
  8. * Patients on non-investigational regimens or on investigational new drug (IND)-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible
  9. * Patients on IND studies (for hematologic malignancies) utilizing Food and Drug Administration (FDA) approved commercially available drugs are eligible
  10. * Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND
  11. * Newly diagnosed MDS or AML, as well as MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy and benefiting from their front-line therapy. Patients with relapsed and/or refractory AML, MDS, MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML) who are either salvage 1 or salvage 2 are eligible for these salvage cohorts if they are within the first 3 cycles of salvage 1 or salvage 2 therapy
  12. * Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid blast phase of MPN and chronic myeloid leukemia (CML) are allowed
  13. * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 at study entry
  14. * Serum creatinine =\< 1.5 mg/dL (unless due to leukemia or other hematologic malignancy)
  15. * Total bilirubin =\< 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's (unless due to leukemia or other hematologic malignancy)
  16. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.0 x ULN (unless due to leukemia or other hematologic malignancy)
  17. * Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
  18. * Extramedullary disease is allowed as long as it can be measured and followed for response
  1. * Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  2. * Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk
  3. * Acute Promyelocytic leukemia (APL)

Contacts and Locations

Study Contact

Maro Ohanian
CONTACT
713-792-2631
mohanian@mdanderson.org

Principal Investigator

Maro Ohanian
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Maro Ohanian, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-11
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2018-10-11
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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