Chronic lymphocytic leukemia/small lymphocytic lymphoma
Conditions
Interventions
Ibr regimen:Ibrutinib monotherapy
Ibr-Clb regimen:Ibrutinib plus chlorambucil
Sponsors
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 65 or above; 2. ECoG score 0-2; 3. The diagnosis of CLL / SLL met the published diagnostic criteria (iwll 2018 Edition); 4. Patients who meet at least one of the following active disease indications to be treated (iwcl2018 standard); 5. Patients who have not received CLL / SLL treatment before; 6. Patients with life expectancy > 6 months since randomization; 7. Adequate hematological function, defined as neutrophil count (ANC) >= 1000 / L (independent of growth factor support for at least 7 days before screening) and platelet count >= 50000 / L (independent of blood transfusion and growth factor support for at least 7 days before screening); 8. Adequate liver function, defined as serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30 ml / min; 10. Patients who are willing to receive all outpatient treatment, all laboratory monitoring and all radiological assessment in the institution giving the study drug throughout the study period; 11. Fertile women (wobcp) and sexually active men were required to use contraception during and after the study according to the contraceptive methods of the subjects in the relevant clinical trials; 12. Subjects must be able to go to the institution responsible for dispensing the study drug throughout the study period and receive all outpatient treatment, all laboratory monitoring, and all radiological assessments; 13. The subjects (or the legally recognized representatives of the subjects) must sign the informed consent form (ICF) to explain that they understand the purpose of the study and the treatment to be implemented in the study, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known central nervous system (CNS) lymphoma or leukemia; 2. Patients with known lymphoblastic leukemia, history of Richter's transformation or suspected Richter's transformation at present; 3. Patients with uncontrolled autoimmune hemolytic anemia or primary thrombocytopenic purpura; 4. Any therapy (including chemotherapy, radiotherapy and / or monoclonal antibody, etc.) previously expected to be specifically used for the treatment of CLL / SLL; 5. Patients who received any immunotherapy, vaccine or research drug within 4 weeks before randomization; 6. Patients who had used corticosteroids within one week before the first administration of the study drug, except inhaled steroids, topical steroids or other topical steroids for asthma. Patients who need systemic prednisone (or equivalent corticosteroid) with daily dose > 20 mg for steroid treatment or who need steroid for leukemia control or white blood cell count reduction were excluded; 7. Patients who underwent major surgery within 4 weeks before randomization; 8. Patients with previous history of malignant tumor (except some cases); 9. Patients with active and clinically significant cardiovascular diseases at present; 10. Patients who can't swallow capsules or tablets may have significant effect on gastrointestinal function and / or inhibit intestinal absorption; 11. Patients with uncontrolled active systemic fungal, bacterial, viral or other infections, or requiring intravenous (IV) antibiotics; 12. Patients with known history of human immunodeficiency virus (HIV) infection; 13. Patients with active hepatitis B or C infection; 14. Patients with a history of stroke or intracranial hemorrhage within 6 months before recruitment; 15. Patients with life-threatening diseases, medical conditions or organ system dysfunction, and according to the opinions of researchers, these conditions may affect the safety of patients or cause risks to the research; 16. Patients requiring anticoagulant therapy with warfarin or equivalent vitamin K antagonist; 17. Patients who need to be treated with strong CYP3A4 / 5 and / or CYP2D6 inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;safety and toxicity; | — |
Countries
China
Contacts
Public ContactJianqing Mi
Department of Hematology, Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
Outcome results
None listed