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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT07201233
Eligibility Criteria:
Inclusion Criteria:
* 1\) Ages 60-80 years , gender unlimited;
* 2\) Patients clinically diagnosed with MDS or AML;
* 3\) Completed chemotherapy and clinically diagnosed with bone marrow suppression grade 2 or above;
* 4\) Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
* 5\) Normal cardiac function;
* 6\) Patients with ECOG 0-2;
* 7\) Patients or their families have been informed and voluntarily signed a written informed consent form.
Exclusion Criteria:
* 1\) Other factors that may cause abnormalities in white blood cells and neutrophils, such as concurrent infections, invasive procedures, etc.
* 2)Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia, etc.). Any unstable systemic diseases: including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association NYHA classification ≥ III,), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases.
* 3\) Any other uncontrolled active diseases that may interfere with participation in the trial;
* 4\) Concurrent diagnosis of malignant tumors in other organs;
* 5\) Concurrent diagnosis of other hematological disorders;
* 6\) Inability to understand or comply with the study protocol;
* 7\) Individuals deemed unsuitable for participation in this trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT07201233
Study Brief:
Protocol Section:
NCT07201233