Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission

Korábbi kezelés

• Contraindication to any drug in the study

Más betegség

• Seropositive for or active viral infection with HBV or HCV
• Human immunodeficiency virus (HIV) infection
• Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
• Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
• Any uncontrolled active systemic infection

Laborértékek

• QTc (corrected by Fridericia formula): >480ms;

Egyéb

• If female, the patient is pregnant or breast-feeding

• Patients were informed about this study and voluntarily signed written informed consent
• Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
• DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
• Life expectancy > 3 months
• Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.