A Phase 2 interventional study of Zanubrutinib, Bendamustine and Rituximab in Waldenstrom Macroglobulinemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
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
WM not only has the characteristics of lymphoma, such as lymphadenopathy, hepatosplenomegaly, and tumor cells expressing CD20, but also has the characteristics of myeloma, such as secreting monoclonal IgM, and tumor cells expressing plasma cell differentiation marker CD38, etc. Clinical studies have also shown that BR regimen and BTK inhibitor zanubrutinib are effective for WM.
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. This prospective phase II study was designed to evaluate the rate of deep response in newly diagnosed symptomatic WM. Eligible patients received ZBR for 6 cycles followed by zanubrutinib monotherapy for an additional 6 months.
365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's planned enrollment of 42 is close to the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The specific conditions are as follows:
The indications for the treatment of indolent lymphoma mainly include (at least one of the following conditions):
Exclusion Criteria:
Patients were treated with ZBR regimen for 6 cycles, followed by zanubrutinib monotherapy for an additional 6 months.
Drug: Zanubrutinib, Bendamustine and Rituximab
Zanubrutinib, 160mg orally, twice a day; Bendamustine 70 mg/m2 on days 1 and 2 of each cycle; Rituximab (375 mg/m2 intravenously on day 0 of each cycle. ZBR was administered every 4 weeks for a total of 6 cycles, followed by maintenance therapy with zanubrutinib monotherapy for another 6 months.
Best combined complete response (CR) and very good partial response (VGPR)
To evaluate the efficacy of zanubrutinib plus bendamustine and rituximab (ZBR) regimen in the treatment of newly diagnosed WM patients, mainly the best deep response rate, namely the best deep response rate (VGPR and above).
Time frame: up to the end of 12 cycles of treatment(each cycle is 28 days)
Overall objective response rate (ORR), complete response rate(CR),major response rate(MR)
using criteria from 6th international workshop on WM
Time frame: up to the end of 12 cycles of treatment(each cycle is 28 days)
Time to response, time to best response
Defined as after initiation of treatment， the time interval between the first documented remission of disease
Time frame: up to the end of 12 cycles of treatment(each cycle is 28 days)
Overall survival(OS)
3-year OS rate after treatment
Time frame: Up to 3 years after the end of treatment
Progression free survival(PFS)
3-year PFS rate after treatment
Time frame: Up to 3 years after the end of treatment
Duration of Response
DOR is defined as the time from the first occurrence of overall response (CR, PR or MR) until disease progression or death due to any cause.
Time frame: Up to 3 years after the end of treatment
Time to Next Treatment
Defined as the amount of time from the start of trial until the patient requires a new form of treatment to treat their WM
Time frame: Up to 3 years after the end of treatment
Safety of treatment regimens
Defined as Treatment-related adverse reactions in patients receiving treatment under this study protocol
Time frame: Up to 3 years after the end of treatment
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Waldenstrom Macroglobulinemia→
Institute of Hematology & Blood Diseases Hospital, China