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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05832320
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed APL patients (WHO 2008 diagnostic classification);
* 18-75 years old;
* Liver function: propionate hydrogentransferase (ALT) and aspartate hydrogentransferase (AST) ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value;
* Renal function: muscle salt ≤ 3 times the upper limit of normal value;
* The physical strength score is 0-2 (ECOG);
* White blood cells ≤ 10×109/L;
* Subjects must sign an informed consent form.
Exclusion Criteria:
* Subjects who have participated in other clinical trials within 30 days;
* Pregnant and lactating subjects;
* Subjects who are known to be HIV-positive in serological tests;
* Subjects who have viral hepatitis serological test positive;
* Subjects who have severe arrhythmia, abnormal electrocardiogram (QT\>500ms);
* Subjects who suffer from mental illness or unable to cooperate with the research treatment and monitoring requirements due to other diseases;
* Subjects who participate in other clinical research at the same time;
* Subjects who fail to sign the informed consent form;
* Other conditions that the researchers think are not suitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05832320
Study Brief:
Protocol Section:
NCT05832320