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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT04260932
Eligibility Criteria:
Inclusion Criteria:
1. Relapsed and refractory B-cell lymphoma with:
Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);
2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
3. Double positive expression of CD19 / CD20 in B cells;
4. Ages 1 to 80 years, including boundary values;
5. ECOG score 0-3 points;
6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;
7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.
Exclusion Criteria:
1. patients with organ failure:
* Heart: NYHA heart function grade IV;
* Liver: Grade C that achieves Child-Turcotte liver function grading;
* Kidney: kidney failure and uremia;
* Lung: symptoms of respiratory failure;
* Brain: a person with a disability;
2. Active infections that are difficult to control;
3. Human immunodeficiency virus (HIV) positive;
4. Liver and kidney function: total bilirubin \> 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 5 × ULN, serum creatinine clearance rate 60mL / min;
5. GVHD ≥ 2 or anti-GVHD treatment;
6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
7. pregnant or lactating women;
8. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
9. Patients who participate in other clinical studies at the same time;
10. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
80 Years
Study:
NCT04260932
Study Brief:
Protocol Section:
NCT04260932