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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT06536959
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
* Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
* Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
* The toxic and side effects caused by the last treatment should be recovered.
* Eastern Cooperative Oncology Group score of 0 to 3 points.
* The organ function is intact.
* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).
* Creatinine≤2×ULN.
* Bilirubin≤2×ULN.
* Karnofsky≥70.
* The expected survival period is at least 12 weeks.
* Non-pregnant, non-breastfeeding women.
Exclusion Criteria:
* Suffering from other untreated or unrelieved malignant tumors within 2 years.
* Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
* Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
* Patients who are unwilling or unable to comply with the protocol.
* Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
* Women who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06536959
Study Brief:
Protocol Section:
NCT06536959