Diffuse large B-cell lymphoma
Conditions
Interventions
treatment group:Rituximab 375mg/m^2 ivgtt d0
Orelabrutinib 150mg po qd
Chidamide 15/20mg(RP2D) po biw
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old 8 g/dL in the last 14 days without blood transfusion or erythropoietin; 4) Total bilirubin <1.5× upper limit of normal (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5×ULN (ALT or AST<5×ULN is allowed in patients with liver metastasis); 6) Serum creatinine <1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) = 50mL/min; 7) Good coagulation function, defined as International normalized ratio (INR) or prothrombin time (PT) <1.5×ULN; 8) Left ventricular ejection fraction =50%; 9) For female subjects of childbearing age, urine or serum pregnancy tests should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the results are negative.If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; (8) If there is a risk of conception, all subjects (male or female) are required to use a contraceptive with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: (1) Central nervous system involvement was confirmed by imaging examination; (2) Concurrent treatment with other approved or under development antitumor drugs; (3) Received chemotherapy, targeted therapy and/or radiotherapy, and autologous stem cell transplantation 4 weeks before screening; (4) Other untreated malignant tumors within five years (except clinically curable carcinoma in situ of the cervix or breast, basal cell or squamous epithelial cell skin cancer, and thyroid tumors); (5) Allergic reactions to the active ingredients or excipients of rituximab, BTKi, or Chidamide; (6) A history of human immunodeficiency disease (HIV) infection (i.e., HIV1/2 antibody positive); (7) Patients with acute or chronic active hepatitis B (non-active HBsAg positive patients and HBsAg negative HBcAb positive patients, will be further HBV-DNA testing, if the detection value is lower than the detection limit of the hospital analysis method, can be enrolled) or acute or chronic active hepatitis C (HCV antibody negative can be enrolled; Patients with positive HCV antibodies need to be tested for HCV RNA, and can be enrolled if they are below the lower detection limit of the analysis method). Note: Patients who meet the eligibility criteria, hepatitis B surface antigen positive or core antibody positive, need continuous antiviral therapy. (8) Have received live vaccine within 30 days before the first administration (1st cycle, 1st day) (Note: Inactivated virus vaccine for injection is allowed within 30 days before the first administration, but live attenuated vaccine is not allowed); (9) Pregnant or lactating women; (10) The presence of any serious or uncontrolled systemic disease, such as: 1) The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above ? degree, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade =2 chronic heart failure; 3) Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; 4) A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first administration, or there is currently clinically active interstitial lung disease; 5) Active pulmonary tuberculosis; 6) Active or uncontrolled infection that requires systemic treatment; 7) Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; 8) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 9) Poor diabetes control (fasting blood glucose (FBG) > 10 mmol/L); 10) Urine routine indicated urine protein = ++, and confirmed 24-hour urine protein quantity > 1.0 g; 11) Patients with mental disorders who cannot cooperate with treatment; 12) Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers other potential risks unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the maximum tolerated dose (MTD) of chidamide;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;partial response rate (PRR);progression-free survival time (PFS);overall survival (OS);Explore potential predictive biomarkers; | — |
Countries
China
Contacts
Public ContactLiqun Zou
West China Hospital of Sichuan University
Outcome results
None listed