relapsed/refractory B-cell lymphoma
Conditions
Interventions
Treatment Group:Chidamide Tablets combined with PD-1
Sponsors
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who join the study voluntarily must sign an informed consent form before all specific research procedures begin. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the patient's immediate family will sign the informed consent form. 2. Aged 18-70 years (including 18 and 70 years old), no gender limit. 3. Diagnosed as B-cell lymphoma by pathological or histological examination, and relapsed after chemotherapy, radiotherapy or hematopoietic stem cell transplantation, so choose CART cell therapy. 4. The type of lymphoma is aggressive B-cell lymphoma (DLBCL, BL, MCL, etc.). 5. Patients with relapsed/refractory B-cell lymphoma: (1) There are still residual lesions after the main treatment and are not suitable for HSCT (auto/allo-HSCT); (2) Relapse occurs after CR, and is not suitable for receiving HSCT (auto/allo-HSCT); (3) Patients with high risk factors; (4) Relapse or no remission of the disease after hematopoietic stem cell transplantation or cellular immunotherapy. 6. Patients with relapsed/refractory B-cell lymphoma should have evaluable or evaluable lesions. 7. After the patient was treated with CART. 8. The patient's main tissues and organs function well (within 7 days before the start of study treatment): (1) Liver function: ALT/AST = 95%; (4) Cardiac function: Left ventricular ejection fraction (LVEF) >= 40%. 9. Patients must complete all screening assessments listed in the trial protocol. 10. The patient is able to swallow or orally. 11. The patient's peripheral superficial venous blood flow is smooth, which can meet the needs of blood infusion. 12. Patients with ECOG score = 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant (positive urine/blood pregnancy test) or breastfeeding; patients who plan to have children within the past 1 year; or the patient cannot guarantee to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment; 2. Malignant tumors of other systems that need to be treated at the same time; 3. Patients suffering from uncontrollable infectious diseases within 4 weeks before enrollment; 4. Severe organ failure or myocardial infarction within the last 6 months; 5. Active viral hepatitis B/C; 6. HIV-infected persons; or suffering from severe autoimmune diseases or immunodeficiency diseases; 7. The patient has an allergic constitution and is allergic to drugs such as Chidamide and PD-1 monoclonal antibody; 8. Suffering from mental illness; 9. The patient has drug abuse/addiction; 10. According to the judgment of the investigator, the patient has other conditions that are not suitable for inclusion, such as alcoholism, other serious diseases that require combined treatment, serious laboratory abnormalities, and family or social factors, which will affect the safety of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhou Jianfeng
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed