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 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT02013102
Eligibility Criteria:
Inclusion Criteria:
* Age≥18;
* The diagnosis of MDS patients comply WHO2008 standards;
* IPSS score≥0.5;
* WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;
* ECOG PS score: 0-2;
* Expected survival≥3 months;
* Serum bilirubin≤1.5\*ULN, serum ALT and AST≤2.5\*ULN, serum Cr≤1.5\*ULN;
* Subjects signed informed consent form in line with GCP requirements.
Exclusion Criteria:
* Can not marrow biopsy;
* Previously diagnosed AML;
* Received azacitidine or decitabine treatment any time before;
* Being diagnosed with other malignancies in the prior 12 months;
* Pregnant or lactating women;
* Failure to control systemic fungal, bacterial or viral infection;
* Known or suspected allergy to decitabine;
* Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection;
* Have a history of neurological or psychiatric disorders, including epilepsy or dementia;
* CTCAE 3 or 4 degree peripheral neuropathy;
* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients;
* Using other experimental drugs or participating in other clinical trials in the prior one months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02013102
Study Brief:
Protocol Section:
NCT02013102