Phase II Clinical Study of Zanubrutinib Combined With Bendamustine and Rituximab (ZBR) for Time-limited Treatment of Waldenstrom Macroglobulinemia
This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM
• The gender of the patient is not limited, and the age is ≥18 years old;
• Must meet WM's diagnostic standards;
• The patient is an untreated or patient who has not undergone standard treatment.
• The specific conditions are as follows:
‣ No combined chemotherapy with BTKi, BR, RCD, VRD, CHOP and COP
⁃ No treatment regimen containing fludarabine
⁃ Chlorambucil or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal glucocorticoids)
⁃ The above treatment did not reach the treatment response (MR)
⁃ If the above treatment has been applied, the treatment needs to be stopped for 2 weeks before entering the group to start treatment
• The indications for the treatment of indolent lymphoma mainly include (at least one of the following conditions):
‣ Symptomatic hyperviscosity;
⁃ Symptomatic peripheral neuropathy;
⁃ Amyloidosis;
⁃ Cold agglutinin disease; cryoglobulinemia;
⁃ Disease-related cytopenia (Hb\<100 g/L, PLT\<100×10\^9/L);
⁃ Giant lymph nodes;
⁃ Those with systemic systemic symptoms: for two weeks/recurrent fever (above 38℃) and not caused by infection, or Night sweats and/or weight loss \>10% within 6 months;
⁃ The disease progresses rapidly, for example, the lymph nodes increase by more than 50% within 2 months, and/or peripheral blood lymphocytes absolute value doubling time \<6 months, and/or rapid hemoglobin or platelet non-autoimmune causes slow down
⁃ When there is evidence that the disease has transformed.
• ECOG score ≤ 2 points
• Laboratory examination: neutrophils ≥ 0.75×10\^9/L; platelets ≥ 50×10\^9/L; total bilirubin ≤ 2.5 times upper limit; alanine aminotransferase/aspartate aminotransferase ≤3 times upper limit. Creatinine clearance rate ≥ 30ml/min.
• The patient's expected survival time is ≥ 3 months.