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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT06991920
Eligibility Criteria:
Inclusion Criteria:
* A series of acute leukemia of unknown origin diagnosed in accordance with the 5th edition of the WHO or ICC classification standards.
* Age ≥ 14 years old, regardless of gender.
* The ECOG performance status score is ≤ 2.
* Conform to the following organ functional status: total bilirubin \< 1.5×ULN, AST and ALT ≤ 2.5×ULN; blood Cr \< 1.5×ULN; myocardial enzymes \< 2×ULN; serum amylase ≤ 1.5×ULN; echocardiography indicates that the left ventricular ejection fraction (LEF) \> 50%. (In the case of patients without a previous history of liver or kidney basic disease, if liver and kidney function abnormalities exceed the aforementioned inclusion criteria and the researcher determines that the liver and kidney function abnormalities are caused by acute leukemia itself, they may be included in the group at the researcher's discretion).
* Understand and sign the informed consent form and agree to abide by the research requirements.
Exclusion Criteria:
* Concurrent with other serious and/or uncontrollable underlying diseases: accompanied by other malignant diseases requiring treatment, acute or chronic hepatitis, severe pancreatic or kidney diseases; other serious and/or life-threatening underlying diseases.
* Pregnant or lactating women.
* Positive for anti-HIV test.
* Mental disorders that may prevent the subject from completing the treatment or giving informed consent.
* The investigator deems the subject unsuitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT06991920
Study Brief:
Protocol Section:
NCT06991920