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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT04740203
Eligibility Criteria:
Inclusion Criteria:
* Ageā„15 years old
* Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
* The immunophenotype of leukemia cells were CD19 and CD22 positive
* Ph- or Ph- like negative
* Anticipated survival time more than 12 weeks;
* Those who voluntarily participated in this trial and provided informed consent.
Exclusion Criteria:
* History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
* Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* Pregnant (or lactating) women;
* Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
* Active infection of hepatitis B virus or hepatitis C virus;
* Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
* Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
* Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
* Other uncontrolled diseases that were not suitable for this trial;
* Patients with HIV infection;
* Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT04740203
Study Brief:
Protocol Section:
NCT04740203