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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT06927232
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old
* Diagnosed as higher-risk MDS (IPSS intermediate-2/high-risk, or IPSS-R \>3.5, or IPSS-M moderate high-, high-, very high-risk)
* Untreated patients
* Liver and kidney function less than 2 times of upper limit of normal
* ECOG≤2 and expected survival more than 6 months
* Informed consent signed
Exclusion Criteria:
* With active infection
* Other malignant tumors
* Obvious abnormal liver and kidney function, or abnormal function of other organs
* Combined with myelofibrosis
* Have undergone bone marrow transplantation
* Pregnant or lactating women, or men who have recent reproductive needs
* Allergic to azacytidine, Rotercept or excipients
* History of polysorbate 80 allergy
* Refuse to sign informed consent
* Researchers consider it inappropriate to participate in the experiment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06927232
Study Brief:
Protocol Section:
NCT06927232