R/R Diffuse large B-cell lymphoma
Conditions
Interventions
Exp. group:BTK inhibitor
Exp. group:PD1
Exp.group:XPO1
Sponsors
Sichuan Academy of Medical Sciences Sichuan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, gender is not limited; 2. ECOG score 0-2 points; 3. Diffuse large B-cell lymphoma (DLBCL) in the high-risk group diagnosed according to histopathology, and meet any of the following: 1). Refractory DLBCL was defined in this study as the first-line standard immunochemotherapy regimen 4 cycles of treatment failed to achieve PR; 2). Relapsed DLBCL refers to re-progression after>= 2 lines of treatment, or after autologous stem cell transplantation to stabilize the disease (whether the high-risk patients with recurrence within 6 months are included is at the discretion of the investigator); 3). Diffuse large B patients with follicular transformation are allowed to enroll 4. At least one measurable lesion according to Lugano 2014 criteria 5. Bone marrow hematopoietic function is basically normal, blood routine: white blood cell count> 3000/uL, absolute neutrophil count >= 1.5x10 9 /L (granulocyte colony-stimulating factor is allowed), platelet count >= 75x10 9 /L (blood transfusion is allowed to reach The minimum platelet count)), hemoglobin >= 8.0g/dL (permit pre-transfusion of red blood cells or use of recombinant human erythropoietin). If the peripheral blood index is abnormal due to lymphoma invading the bone marrow or spleen, the investigator can judge whether it is suitable for enrollment; 6. Normal function of major organs: renal function needs to meet: creatinine = 50%, asymptomatic arrhythmia; 7. Voluntary test, signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiac insufficiency and cardiac ejection fraction EF less than 50%; or patients with a history of clinically significant QTc interval prolongation (men > 450ms, women > 470ms), ventricular tachycardia (VT), atrial Patients with fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), symptomatic coronary heart disease requiring medical therapy; with severe pulmonary insufficiency (obstructive and or Restrictive ventilation disorder), investigators evaluate those who cannot tolerate chemotherapy regimens; 2. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 3. Known history of human immunodeficiency virus (HIV) infection or active hepatitis C virus (HCV) or hepatitis B virus (HBV). Active HBV infection is confirmed by a positive test for HBV surface antigen or a positive test for hepatitis B core antibody and a positive test for HBV DNA by polymerase chain reaction (PCR). 4. There is severe active infection before chemotherapy, and the investigators evaluate those who cannot tolerate chemotherapy; 5. Less than 6 weeks after major organ surgery; 6. There are clinical symptoms of brain dysfunction or serious mental illness that cannot be understood or complied with research proposal; 7. Patients with drug addiction and long-term alcohol abuse that affect the evaluation of the test results; those with other malignant tumors who need treatment; 8. Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response; | — |
Countries
China
Contacts
Public ContactJuan Huang
Outcome results
None listed