Houston, Texas 77030


Purpose:

If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving calcium disodium edetate (Ca-EDTA) or dimercaptosuccinic acid (DMSA) to patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) while receiving standard chemotherapy can help to lower the level of metals found in the bone marrow and blood. Researchers think lowering the level of metals found in the blood/bone marrow may help to control the disease and/or improve response to chemotherapy. Researchers also want to find the highest tolerable dose of Ca-EDTA and DMSA that can be given to AML or MDS patients. The safety of Ca-EDTA and DMSA will also be studied. This is an investigational study. Ca-EDTA and DMSA are both FDA approved and commercially available as metal detoxifiers (medications that lower the amount of metals in the blood). It is considered investigational to give Ca-EDTA and DMSA to patients with AML/MDS who are receiving chemotherapy. Up to 24 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age >/= 18 years at the time of signing the informed consent form. 3. Diagnosis of 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. Newly diagnosed (or untreated) myeloid blast phase of MPN (including myeloid blast phase of CML. Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS. Newly diagnosed (or untreated) MDS/MPN (regardless of cytogenetic/molecular status). 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. 4. Patients on non-investigational regimens or on IND-exempt MD Anderson studies of approved drugs are also eligible. 5. 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 6. Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 at study entry 7. Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy): a) Serum creatinine </= 1.5 mg/dL; b) Total Bilirubin </=2.0 x upper limit of normal (ULN), unless the patient has Gilbert's; c) AST (SGOT) and/or ALT (SGPT) </= 2.0 x ULN. 8. 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. 9. Extramedullary disease is allowed as long as it can be measured and followed for response. Exclusion Criteria: 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.


NCT ID:

NCT03630991


Primary Contact:

Principal Investigator
Maro Ohanian
M.D. Anderson Cancer Center

Maro Ohanian
Phone: 713-792-2631
Email: mohanian@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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