Chronic lymphocytic leukemia/small cell lymphoma and mantle cell lymphoma
Conditions
Interventions
Group 1:Zanubrutinib
Group 2:Ibrutinib
Group 3:Initial maintenance therapy with ibrutinib and then switched to zanubrutinib due to intolerance or voluntary
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The treatment requirements are consistent with the criteria for initiation of treatment in iwCLL 2018, so at least 1 of the following should be met: (1) Evidence of progressive bone marrow failure manifested by anemia (eg, hemoglobin = 6 cm below the left costal margin) or progressive or symptomatic splenomegaly (> 13 cm). (3) A large number of lymph nodes (ie, the longest diameter >= 10 cm) or progressive or symptomatic lymphadenopathy. (4) Progressive lymphocytosis, with an increase of > 50% within 2 months, or lymphocyte doubling time =10% in the past 6 months. 2) Significant fatigue (ie, Eastern Cooperative Oncology Group [ECOG] performance status score of 2 or worse; inability to work or perform daily activities). 3) Fever >=100.5°F or 38.0°C for 2 weeks or more and no evidence of infection. 4) Night sweats for >=1 month and no evidence of infection. 2. Known deletion status of chromosome 17. 3. Previously received experimental or approved covalent BTK inhibitor therapy, as well as monotherapy or combination therapy with other drugs. Patients may have received an unlimited number of lines of prior therapy. 4. Prior treatment-related AEs must return to <= grade 1 or pre-treatment baseline levels, except for alopecia.
Exclusion criteria
Exclusion criteria: 1. Known or suspected Richter's transformation into diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia or Hodgkin's lymphoma at any time before enrollment. 2. Known or suspected history of CLL/SLL involving the central nervous system (CNS). 3. History of >= grade 2 arrhythmia during previous covalent BTK inhibitor therapy. 4. Patients with major bleeding events during previous BTK inhibitor therapy. 5. Active secondary malignant tumor. Patients with treated secondary malignancies in remission, life expectancy >2 years, and sponsor-approved patients were eligible to participate in the study. 6. Major surgery within 4 weeks prior to the planned start of study treatment. 7. There is a history of drug-induced pneumonia or a history of present illness. 8. Persistent drug-induced liver injury, primary biliary cirrhosis, extrahepatic obstruction and cirrhosis caused by cholelithiasis. 9. History of allogeneic or autologous SCT or CAR-T therapy within the past 60 days. 10. Active uncontrolled autoimmune cytopenia who has not received a stable regimen and dose for at least 4 weeks prior to enrollment (eg, autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]). Patients with known contraindications to treatment regimens (zanubrutinib, ibrutinib). 11. Patients with coagulation disorders or requiring long-term anticoagulation. 12. Known hepatitis B (HBV) and hepatitis C (HCV) infection (HBV infection refers to HBsAg positive and HBV-DNA detectable); and patients with other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected patients (HBV-DNA >= 10^4). 13. Pregnant or lactating patients and female patients of childbearing age who are unwilling to take contraceptive measures. 14. Patients who have received organ transplants in the past. 15. Has severe active infection. 16. Has a history of severe neurological or psychiatric disorders, including dementia or epilepsy. 17. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 18. Patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYu Li
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed