A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia

Launched by SHANGHAI CHANGZHENG HOSPITAL · Aug 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with newly diagnosed Waldenström's macroglobulinemia, a type of blood cancer. The researchers are examining how well a drug called zanubrutinib works when combined with two other medications, bendamustine and rituximab. They hope that this combination will lead to deeper and longer-lasting remissions compared to using zanubrutinib or the other two treatments alone. The goal is to provide a treatment that is effective but also time-limited, which could help reduce the amount of therapy needed over a patient's lifetime.

To participate in the trial, patients must be newly diagnosed with Waldenström's macroglobulinemia and show that they need treatment according to specific medical guidelines. Eligible participants should generally be in good health, able to take medications by mouth, and not have serious organ issues or other significant health conditions. During the trial, participants will receive the combination treatment and be closely monitored for its effects. It's important for potential participants to discuss this opportunity with their healthcare team to see if it might be a good fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all of the following criteria to be enrolled:
• • 1. Newly diagnosed patients with waldenström's macroglobulinemia meeting at least one criterion for treatment according to consensus panel criteria from the eleventh IWWM.
• • 2. ECOG score: 0-3 points, estimated survival time exceeding 3 months.
• • 3. Did not receive any treatment for Waldenström's macroglobulinemia before screening, except for glucocorticoid therapy for autoimmune hemolysis.
• • 4. 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.
• • 5. 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.
• • 6. No history of paroxysmal atrial fibrillation or chronic persistent atrial fibrillation.
• • 7. Able to swallow and Oral administration.
• • 8. The subjects complete all screening and evaluations listed in all trial protocols.
• • 9. The subjects who signed the informed consent form for chemotherapy.
• Exclusion Criteria:
• • 1. Waldenström's macroglobulinemia with amyloidosis or POEM syndrome
• • 2. 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.
• • 3. Accompanied by other serious unstable diseases, including heart failure, renal failure, liver failure, hemorrhagic diseases, uncontrollable diabetes, etc.
• • 4. 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.
• • 5. Serious infectious diseases (uncured pulmonary tuberculosis, pulmonary aspergillosis, etc.).
• • 6. 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).
• • 7. Individuals with epilepsy, dementia, and other mental disorders who require medication treatment and are unable to understand or follow the research protocol.
• • 8. Drug use, medical, psychological, or social conditions that may interfere with participants' participation in the study or evaluation of the results.
• • 9. Pregnant and lactating women.
• • 10. Patients who are accounted to be not appropriate for this trail by investigator.