Monitoring, Detoxifying, and Rebalancing Metals During Front Line Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 2/20/2019 |
| Start Date: | October 11, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Maro Ohanian |
| Email: | mohanian@mdanderson.org |
| Phone: | 713-792-2631 |
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.
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.
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
7. Laboratory test results within these ranges (unless due to leukemia or other
hematologic malignancy): a) Serum creatinine x upper limit of normal (ULN), unless the patient has Gilbert's; c) AST (SGOT) and/or
ALT (SGPT)
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.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Maro Ohanian
Phone: 713-792-2631
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