Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01400633
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including Chronic Myelomonocytic Leukemia (CMML)
* Patients with an International Prognostic Scoring System \>= Int-1
* Patients who were never treated with hypomethylating agent (azacitidine and decitabine)
* Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations. Women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization), in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy
* Patients who signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
* Patients diagnosed with Acute Myelogenous Leukemia (AML, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases
* Patients with active infection of virus or bacteria
* Patients who used to be treated with azacitidine or decitabine
* Patients who are hypersensitive to excipients of decitabine
* Patients who are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01400633
Study Brief:
Protocol Section:
NCT01400633