A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib

Inclusion Criteria:

• Age ≥18 years old， male or female
• Diagnosed as CLL/SLL based on iwCLL2018 criteria
• Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection hadmeasurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm andhad a measurable vertical dimension
• ECOG score 0-2
• Slowly responding to ibrutinib is defined as: patients only achieve SD after 3 cyclesof ibrutinib treatment
• Life expectancy ≥6 months
• Adequate bone marrow reserve and adequate organ function
• Participant or his/her legal agent must be willing to sign a written informed consentdocument.

Exclusion Criteria:

• Evidence of active Richter's transformation or any evidence of disease progression onibrutinib therapy.
• CNS involvement by CLL
• Present or prior history of other malignant neoplasms, unless radical treatment hasbeen performed and there is no evidence of recurrence or metastasis in the last 5years
• Uncontrolled or significant cardiovascular disease
• Active hemorrhage within 2 months prior screening
• Cerebral ischemic stroke or bleeding within 6 months prior screening
• Other surgery history within 6 weeks prior screening
• Uncontrolled active systemic fungal, bacterial, virus or other microbe infection, orintravenous injection of antibiotics needed
• Anti-tumor corticosteroids treatment 1 week prior orelabrutinib and anti-tumor herbalmedicine treatment within 4 weeks prior screening
• Activated or uncontrolled hepatitis virus B infection (HBsAg positive with/or HBc Abpositive and HBV-DNA titration positive), HCV-RNA positive, HIV positive.
• Accepted live vaccine or immunization within 4 weeks prior screening
• Medium / strong inhibition or induction of cytochrome P450 CYP3A is needed.
• Allergy to orelabrutinib or the subsidiary (or supplementary) material (Hydroxypropylmethylcellulose acetate succinate, mannitol, cross-linked sodiumcarboxymethylcellulose, hydroxypropyl cellulose, silica and magnesium stearate)
• Obvious gastro-bowel disease which may influence the intaking, transportation orabsorption of the drug, or total gastrectomy.
• Pregnant or breeding women, or women of childbearing age who are unwilling to takecontraceptive measures during the whole study period and within 180 days after thelast administration of the study drug; non surgically sterilized men who are unwillingto take contraceptive measures during the whole study period and within 180 days ofthe last administration of the study drug.
• Potentially life-threatening situation, or severe organ dysfunction, or situations theresearchers think not suitable for the trial
• Any mental or cognitive impairment which may limit the understanding andimplementation of informed consent or the compliance with the study.