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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib | Drug | Orelabrutinib monotherapy for CLL/SLL 12 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Grade 3 hypertension and atrial fibrillation | Number of patients with grade 3 or above hypertension during treatment/total number of patients enrolled; number of patients with atrial fibrillation during treatment/total number of patients enrolled. | at the end of 12 cycles of treatment((each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | at the end of 12 cycles of treatment(each cycle is 28 days) |
| CR | complete response | at the end of 12 cycles of treatment(each cycle is 28 days) |
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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:
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;
Biochemical examination shall meet the following standards:
TBIL < 2.0×ULN, CLL/SLL involved liver or diagnosed Gilbert syndrome (normal direct bilirubin), total bile red ≤ 3 ULN; ALT and AST < 2.5×ULN (for CLL/SLL involved liver, ALT and AST < 5×ULN); Endogenous creatinine clearance ≥30ml/min (Cockcroft-Gault formula). 8. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 9. Expected survival > 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:
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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 ≥ 25. ECOG score ≤2 points; 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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Ding, PHD | Contact | 13864151105 | dingmei1105@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | 250021 | China |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
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| PFS | progression-free survival | From the date of receipt of the first investigational medication to the date of first onset of disease progression or death from any cause, whichever comes first.up to 2 years |
| OS | Overall Survival | From the date of receipt of the first study medication to the date of death from any cause.up to 2 years |
| Improvement rate of abnormal indicators | Continuous improvement in hematology (hemoglobin level increased to greater than 110g /L or ≥20 g/L increase from baseline, or platelet count increased to ≥50% from baseline, without blood transfusion/growth factors) | After 12 cycles of treatment(each cycle is 28 days) |
| QoL | Quality of Life score | at the end of 12 cycles of treatment(each cycle is 28 days) |