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:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT07085156
Eligibility Criteria:
Inclusion Criteria:
* Age 14-70 (including boundaries) and gender;
* Diagnosis of MDS is confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests;
* IPSS-R intermediate-risk or higher-risk or IPSS-M intermediate-risk or higher-risk MDS; transfusion-dependent MDS;
* ECOG score≤ 3 points;
* Have appropriate organ function, and laboratory results within 7 days prior to the start of trial treatment need to meet the following criteria:
* Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN);
* Alanine aminotransferase (ALT) ≤ 3x ULN;
* Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included;
* Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;
* Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN;
* Left ventricular ejection fraction (LVEF) ≥50%;
* Voluntarily signing the informed consent, understanding and complying with the requirements of the study, good compliance, and cooperating with the follow-up visits.
Exclusion Criteria:
* Allergies or contraindications to any of the drugs in the protocol;
* Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;
* Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);
* Active autoimmune diseases such as SLE, rheumatoid arthritis, etc;
* Patients with neurological or psychiatric disorders;
* The patient is pregnant or breastfeeding;
* Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.
* Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
70 Years
Study:
NCT07085156
Study Brief:
Protocol Section:
NCT07085156