phase iv observational study of orelabrutinib in the treatment of chronic lymphocytic leukemia/small cell lymphoma

Conditions: CLL/SLL

Summary: this was a multicenter observational study of orelabrutinib in the treatment of cll/sll. patients were treated with orelabrutinib for 12 cycles. the primary end points were grade 3 hypertension and incidence of atrial fibrillation, and the secondary end points were improvement in abnormal markers, orr,cr,pfs, and os.


Eligibility criteria:
inclusion criteria: * 1. age 18-80 years old, gender unlimited; 2. chronic lymphocytic/small cell leukemia was confirmed by histopathology based on iwcll criteria; 3. according to the iwcll standard, the treatment can be certified 4. ipi ≥ 2 5. ecog score ≤2 points; 6. measurable lesions detected by enhanced computed tomography/magnetic resonance imaging (ct/mri) : at least one lymph node with a maximum axis of more than 1.5cm and a measurable vertical dimension; for patients with chronic lymphocytic leukemia, only peripheral circulating lymphocyte count must be required. 5000/μl (or 5×10\^9/l); 7. if the major organs are functioning normally, the following criteria are met: 1. the standard of blood routine examination shall meet: neutrophil absolute value (anc) ≥1.0×109/l, platelet (plt) ≥30×109/l; unless it is confirmed that the bone marrow and hematopoietic deficiency is caused by cll/sll; 2. biochemical examination shall meet the following standards: tbil \ 6 months; 10. patients voluntarily participated in this study and signed written informed consent. exclusion criteria: * 1. patients who have received other btk inhibitors in the past and have progressed; 2. patients with grade 3 hypertension 3. patients with atrial fibrillation 4. richter's syndrome is or has been confirmed by biopsy pathology; 5. has active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura; 6. present or past malignancies other than cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder carcinoma; 7. received glucocorticoid therapy (at a dose of 20 mg/ day or higher than prednisone or equivalent) within 14 days prior to initial administration, except for inhalation, topical, intraarticular, and prophylactic use before or after use of iodized contrast agent; after discussion with the group leader, higher doses and longer steroid therapy may be permitted in the following situations: 1. treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with cll/sll disease; 2. short-term (within 14 days) use to treat non-active infections in diseases not associated with cll/ srl (e.g., arthritis, asthma) to acute exacerbations, including dose adjustments of steroids required for adrenal insufficiency; 8. patients who have undergone major surgical operations (tests for diagnostic purposes) or participated in clinical trials of drugs/devices within 4 weeks; 9. have uncontrolled or significant cardiovascular disease, including: 1. new york heart association (nyha) class ii or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment at the time of screening, left ventricular ejection fraction (lvef) \&lt in the six months prior to the initial administration of the study drug; 50%; 2. primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, unestablished cardiomyopathy); 3. clinically significant history of prolonged qtc interphase, or women with interphase qtc in screening period \&gt; 470ms, male \&gt; 450ms; 4. subjects with symptomatic or medicated coronary heart disease; 5. patients with uncontrolled hypertension (on the basis of improving their life style, their blood pressure is still not up to the standard after more than 1 month with the application of reasonably tolerable enough 2 or more antihypertensive drugs (including diuretics), or their blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs); 10. abnormal coagulation (inr \> 1.5 or prothrombin time (pt) \> uln+4 s or aptt \&gt; 1.5 uln) or had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or had what the investigator considered a definite tendency to bleed; 11. arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 12 months before enrollment; 12. clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 13. active or uncontrolled hbv (hbsag positive and hbv dna titer positive), hcv ab positive or hiv positive; 14. uncontrolled, active systemic fungal, bacterial, viral or other infection (defined as showing persistent signs/symptoms associated with the infection despite no improvement with appropriate antibiotics or other treatment); 15. allergic disposition or hypersensitivity to obutinib or any other component of the applicable investigational drug; 16. those who have received potent cyp3a4 inhibitor therapy within 7 days before enrollment, or potent cyp3a4 inducer therapy within 12 days before enrollment, or must also take cyp3a severely inhibiting or strongly inducible drugs; 17. those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 18. participated in clinical trials of other antitumor drugs within 4 weeks before enrollment; 19. pregnant and lactating women and subjects of childbearing age who do not want to take contraceptive measures; 20. poor compliance or inability to follow up regularly; 21. patients with life-threatening conditions or severe organ dysfunction are deemed unfit to participate in the study; 22. the investigator determines other circumstances that may affect the conduct of clinical studies and the determination of study results.