This study aims to investigate the treatment of navie CLL/SLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.
65 years of age and older or between 18 and 65 years of age with severe illness (non-CLL/SLL associated CIRS ≥ 6);
ECOG performance status (PS) level 0~2；
Expected survival is not less than 12 weeks;
Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or histopathology according to IWCLL2008 criteria, and CD20 positive;
Patients with 17P- chromosome abnormalities or TP53 mutations;
Current or previous biopsy pathology confirms conversion to Richter's syndrome;
Have active and uncontrolled autoimmune cytopenias, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura;
Patients with central nervous system invasion;
Single group
Orelabrutinib and BG
DrugDrug: Orelabrutinib Orelabrutinib 200mg, po, qd，C2-C7. Twenty-eight days for a cycle. Drug: BG Bendamustin 70mg/m2, IV, d2\&d3 inC1, and then d1\&d2 inC2-6.Twenty-eight days for a cycle. Obintuzumab 100mg IV, d1, 900mg d2, 1000mg d8\&d15 in C1, and then 1000mg/m2 IV, d1 in C2-6. Twenty-eight days for a cycle.
The rate of CR and uMRD
The proportion of patients with CR and undetectable peripheral blood/bone marrow minimal residual disease in the end of combination therapy. Patients with CRi are counted as CR.
The rate of CR/CRu and uMRD
The proportion of patients with CR/CRu and undetectable peripheral blood/bone marrow minimal residual disease in the end of combination therapy. Patients with CRi are counted as CR. CRu is defined as a large spleen size of 16cm or less, and the rest of the indicators meet CR/CRi standards.
The Rate of uMRD
According to the detection of Shihe Gene \[igNGS kit\], no residual leukemia cells were detected in a million peripheral blood or bone marrow cells.
PFS（progression-free survival）
Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.
OS（overall survival）
Overall survival (OS) refers to the time from receiving the first dose to death from any cause.
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