Waldenstrom macroglobulinemia
Conditions
Interventions
single arm:Zanubrutinib combine Dexmethasone
Sponsors
Capital Medical University affiliated Beijing Chaoyang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 or above; 2. Newly diagnosed and advanced WM patients (in line with the iwwm consensus group criteria), pathological reports support the diagnosis of WM, and their life expectancy is at least 4 months. 3. Patients with ECoG score of 0-2. 4. Creatinine clearance rate >= 30 ml / min, AST and alt = 50%. 6. Patients can understand the changes during and after treatment and the choice of treatment methods, and have good compliance with the treatment and follow-up plan. 7. Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with WM related central nervous system symptoms. 2. Patients with evidence of disease transformation. 3. Patients with toxicity of previous anti-cancer treatment >= 1. 4. Currently active patients with clinically significant cardiovascular diseases, such as uncontrolled arrhythmia, hypertension, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 6 months after screening; QTCF prolongation (QTc > 0 480 MS) or other serious ECG abnormalities, including type II atrioventricular (AV) atrioventricular block or grade 3 atrioventricular block; severe dysfunction of heart, lung, liver and other important organs unrelated to WM (cardiac ejection fraction less than 50%, carbon monoxide diffusion capacity caused by chronic respiratory diseases less than 50% of the expected value, serum bilirubin level more than 2 mg / dl, Or ALT or AST levels were 2.5 times higher than the upper limit of normal. 5. Patients who are unable to swallow capsules or have a significant impact on gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, symptomatic inflammatory bowel disease or partial or complete intestinal obstruction. 6. Patients with a history of surgery, radiotherapy or severe infectious diseases within 14 days. 7. Patients with known human immunodeficiency virus (HIV) or active hepatitis B or hepatitis C infection (positive by polymerase chain reaction [PCr]). 8. Pregnant or lactating women and women of childbearing age who refused to take appropriate contraceptive measures during this trial. If the patient was male, he refused to use adequate contraceptive methods or donate semen during the study and within 3 months after receiving the last cycle of drug study. 9. The researchers believe that any life-threatening disease, treatment status or organ system dysfunction may impair the safety of subjects or put the study at risk. 10. Have mental illness, understanding disorder, epilepsy or other reasons unable to control themselves. 11. Patients who are allergic to zebitinib. 12. Patients who participated in another clinical trial within 30 days of the start of the trial and throughout the trial period. 13. Patients who had been diagnosed or treated with another malignant tumor within 2 years before enrollment. 14. The investigator judged the patients who were not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progession free time; | — |
Countries
China
Contacts
Public ContactWenming Chen
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Outcome results
None listed