A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regim… (NCT05979948) | Clinical Trial Compass
UnknownPhase 2
A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia
China60 participantsStarted 2023-08-01
Plain-language summary
This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy of zanubrutinib combined with BR (Bendamustine/Rituximab) regimen in Chinese participants with newly-diagnosed Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the 11th International Workshop on Waldenström's Macroglobulinemia (IWWM). The investigators propose this combination will improve the deep remission compared to single Zanubrutinib or BR regimen and can be a time-limited regimen which will reduce the life-time therapy and benefit the patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed patients with waldenström's macroglobulinemia meeting at least one criterion for treatment according to consensus panel criteria from the eleventh IWWM.
✓. Did not receive any treatment for Waldenström's macroglobulinemia before screening, except for glucocorticoid therapy for autoimmune hemolysis.
✓. No serious damage to main organs, and meet the following laboratory examination indicators: creatinine clearance rate≥40ml/min, total bilirubin≤1.5 times of the upper limit of normal range; AST and ALT≤2.5 times of the upper limit of normal range; Myocardial enzyme≤2 times of the upper limit of normal range; ECHO must demonstrate left ventricular ejection fraction (LVEF) within the normal range, and no ECG abnormality with clinical significance.
✓. Neutrophil count≥1.5×10\^9/L without growth factor therapy within 7 days before screening; Platelet count≥50×10\^9/L without growth factor support or transfusion within 7 days before screening; Hemoglobin≥60 g/L without erythropoietin (EPO) support or transfusion within within 7 days before screening.
✓. No history of paroxysmal atrial fibrillation or chronic persistent atrial fibrillation.
✓. Able to swallow and Oral administration.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: up to the end of 12 cycles of treatment(each cycle is 28 days)
2
The best deep response rate
Timeframe: Time Frame: up to the end of 12 cycles of treatment(each cycle is 28 days)
. The subjects complete all screening and evaluations listed in all trial protocols.
Exclusion criteria
✕. Waldenström's macroglobulinemia with amyloidosis or POEM syndrome
✕. HIV positive, or patients with active hepatitis A, hepatitis B, and hepatitis C infection; Or the number of copies of hepatitis B virus\>10\^2.
✕. Accompanied by other serious unstable diseases, including heart failure, renal failure, liver failure, hemorrhagic diseases, uncontrollable diabetes, etc.
✕. In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required.
✕. Other uncontrolled malignancies (excluding non Melanoma skin cancer, cervical cancer in situ, bladder cancer cancer and breast cancer with disease-free survival of more than 5 years).
✕. Individuals with epilepsy, dementia, and other mental disorders who require medication treatment and are unable to understand or follow the research protocol.
✕. Drug use, medical, psychological, or social conditions that may interfere with participants' participation in the study or evaluation of the results.