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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03488160
Eligibility Criteria:
Inclusion Criteria:
1. Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;
2. The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation;
3. The patient needs to have a lesion that can be used to detect or evaluate the disease.
4. 0\~1 score of physical status score of the eastern cancer cooperation group (ECOG).
5. At the time of collection of peripheral white blood cell counts over 1 \* 10\^9/L;
6. Expected survival time \> 90 days;
7. Patients have the ability to know and sign informed consent.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Uncontrolled infection;
3. HIV infected people, hepatitis B or HCV active stage;
4. Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).
5. Combined with active central nervous system malignant tumor invading;
6. Has abnormal coagulation function, and there are patients with serious thrombus.
7. Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system.
8. Patients who participated in other clinical trials in the past 30 days or in other clinical trials;
9. Researchers believe that patients are not suitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT03488160
Study Brief:
Protocol Section:
NCT03488160