Newly diagnosed and progressed of waldenstrom macroglobulinemia
Conditions
Interventions
Experimental group:Zebutinib + cyclophosphamide + dexamethasone
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Newly diagnosed and progressive WM patients (in line with the IWWM consensus group criteria), the pathology report supports the diagnosis of WM, with a life expectancy of at least 4 months; 3. ECOG score 0-2; 4. Creatinine clearance >= 30 mL/min, AST and ALT = 50%; 6. Patients can understand various changes during and after treatment and the choice of treatment methods, and have good compliance with planned treatment and follow-up; 7. Sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Accompanied by WM-related central nervous system symptoms; 2. Evidence of disease transformation; 3. The toxicity of previous anticancer treatment is >= grade 1; 4. Currently active and clinically significant cardiovascular disease, such as uncontrolled arrhythmia, hypertension, congestive heart failure, any grade 3 or 4 heart disease as defined by the New York Heart Association's (NYHA) functional classification, or a history of myocardial infarction within 6 months of screening; prolonged QTcF (QTc > 480 ms) or other severe ECG abnormalities, including type II atrioventricular (AV) block or grade 3 atrioventricular block; severe abnormalities in the function of vital organs such as the heart, lungs, and liver unrelated to WM (cardiac ejection fraction less than 50%, carbon monoxide dispersion capacity due to chronic respiratory disease less than 50%, serum bilirubin level more than 2 mg/dl, or ALT or AST levels 2.5 times higher than the upper limit of normal); 5. History of other active malignant tumors occurring within 2 years after study entry, except in the following cases: (1) Carcinoma in situ of the cervix that has been adequately treated; (2) Local basal cell or squamous cell carcinoma of the skin; (3) The previous malignant tumor has been controlled or cured (surgery or other methods); 6. Unable to swallow capsules or diseases that have a significant impact on gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease or partial or complete intestinal obstruction; 7. History of surgery within 14 days of enrollment , history of radiotherapy or severe infectious disease; 8. Known human immunodeficiency virus (HIV) or active hepatitis B or C infection (positive by polymerase chain reaction (PCR)); 9. Pregnant or breastfeeding women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial. If the patient is male, refuse to use adequate contraception or donate semen during the study period and within 3 months after receiving the last cycle of drug study; 10. The researchers believe that any life-threatening disease, treatment condition or organ system dysfunction may compromise the safety of the subject or put the research at risk; 11. People with mental illness, comprehension impairment, epilepsy or other reasons unable to control themselves; 12. Those who are allergic to the ingredients of Zanubrutinib; 13. Participate in another clinical trial within 30 days of the start of the trial and throughout the trial period; 14. Another malignant tumor was diagnosed or treated within 2 years before enrollment; 15. The investigator judges that the patient is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Progression Free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial relief, PR;Duration of treatment, DOT;Fixed cycle treatment time;safety;compliance;quality of life; | — |
Countries
China
Contacts
Public ContactWenming Chen
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed