Efficacy and Safety of Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (oFCG) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (oFCG) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
• Age between 18 to 65 years old for both gender.
• Patients have a confirmed diagnosis of CD20-positive chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and meet criteria to initiate first-line treatment per International Workshop on CLL Working Group (IWCLL) 2018 guidelines
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• At least one measurable disease detected by enhanced computerized tomography (CT) or magnetic resonance imaging (MRI). At least one lymph node with the longest axis \>=1.5cm and one measurable vertical dimension.
• With life expectancy \> 6 months.
• Patients must meet the following laboratory examination criteria during 14 days before entry:
⁃ Serum bilirubin \<1.5 Upper Limit of Normal (ULN), other than gilbert syndrome (defined as unconjugated bilirubin\>80%); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN.
⁃ Absolute neutrophil count (ANC)≥0.75×109/L and Platelets≥50×109/L (patients without exposure to G-CSF or blood transfusion within 7 days and no exposure to )