DLBCL
Conditions
Interventions
Group A:BTK inhibitor immunomodulator
Group B:BTK inhibitor
Group C:Immune checkpoint inhibitor
Group D:Selective targeted therapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. ECOG performance status of 0 to 2; 3. Relapsed/refractory diffuse large B-cell lymphoma confirmed by histopathology for transplantation failure or unsuitable for transplantation. 4. At least one 2D measurable lesion with a long diameter of at least 1.5 cm and a vertical diameter of at least 1.0 cm, measured by CT or MRI; 5. Bone marrow hematopoietic function is basically normal, blood routine: WBC >= 3.5x10^9/L, ANC >= 1.5x10^9/L, PLT >= 80x10^9/L, Hb >= 90 g/L. If the peripheral blood indicators are abnormal due to lymphoma invading the bone marrow or spleen, the investigator can judge whether it is suitable for inclusion; 6. Liver function: total bilirubin, ALT and AST are all = 40 ml/min; 8. Echocardiography or radionuclide heart function test, LVEF >=50%; 9. Patients during the reproductive period agree to take appropriate contraceptive measures. Women in childbearing period had negative serum pregnancy test within 2 weeks before enrollment; 10. Agree to provide pathological tissue specimens (20 pieces of wax block or paraffin tissue section); 11. Expected survival>=3 months; 12. Comply with the study protocol and follow-up, and written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to have a history of severe allergies to humanized or murine monoclonal antibodies. Or patients who are known to have any contraindications to the targeted drugs; 2. Patients who have received BTK inhibitors, NK-?B inhibitors, PI3K inhibitors and other drugs in the past; 3. Heart diseases, including unstable angina pectoris, acute myocardial infarction within 6 months before screening, congestive heart failure (NYHA) heart function classification of III or IV, Q-Tc interval greater than 500ms; 4. Those who have undergone second-level or above surgery within three weeks before treatment; 5. Diagnosed with malignant tumor other than lymphoma or receiving treatment, except for the following conditions: (1) Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred >= 5 years before enrollment; (2) Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease; (3) Cervical carcinoma in situ that has received adequate treatment and has no signs of disease; 6. Those who have received other anti-tumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical research within 4 weeks before the start of the study (if the patient receives small molecule targeted drug therapy, the drug can be enrolled for more than 5 half-lives), or have not recovered from the previous toxicity; 7. Obvious abnormal blood coagulation function; 8. Suffer from autoimmune diseases that require treatment, or have a history of syndromes requiring systemic use of steroids/immunosuppressants, such as: pituitary inflammation, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, thyroid function Decline, etc.; 9. Other serious and uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including uncontrollable diabetes, or lung diseases (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm); 10. There is evidence of CNS disease; 11. Those who have received live vaccination within 4 weeks before the start of the study; 12. Known hepatitis B (HBV) (HBsAg positive and HBV-DNA >= 10^4), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA detectable); and other acquired and congenital immunodeficiencies Subjects with diseases, including but not limited to HIV-infected persons; 13. Women during pregnancy or breastfeeding; 14. Patients who have received organ transplantation in the past (except autologous hematopoietic stem cell transplantation); 15. Have serious active infection; 16. Have a history of severe neurological or psychiatric diseases, including dementia or epilepsy; 17. Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in research or evaluation of research results; 18. Patients deemed unsuitable for enrollment by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactXiaoyan Zhou
Fudan University Shanghai Cancer Center
Outcome results
None listed