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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT03281551
Eligibility Criteria:
Inclusion Criteria:
1. Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
2. In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology
3. In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:
1. Getting through 2 treatments of standard chemotherapy with CR not yet obtained
2. Reach CR for the first inducement, but CR lasts for ≦12 months
3. r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment
4. ≧2 times of recurrence
4. Remedial chemotherapy is not used within 4 weeks before cell therapy
5. Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
6. Antibody drug treatment is not received within 2 weeks before cell therapy
7. Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia
8. No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%
9. No contraindications for leukapheresis
10. Expected survival \>3 months
11. Grade 0 or 1 of ECOG performance status
Exclusion Criteria:
1. Pregnant and breastfeeding women
2. Uncontrolled active infection
3. Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
4. Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
5. Stage II-IV Acute/chronic general graft versus host disease
6. Gene therapy has been undergone in the past
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT03281551
Study Brief:
Protocol Section:
NCT03281551