Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM
ConditionWaldenstrom Macroglobulinemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
No combined chemotherapy with BTKi, BR, RCD, VRD, CHOP and COP
Disqualifiers
Malignant tumors (including active central nervous system lymphoma) other than B-NHL have been diagnosed or treated within the past year;
There is clinical evidence that large cell lymphoma transformation has occurred;
Non-lymphoma-related liver and kidney damage: alanine aminotransferase (ALT)> 3 times the upper limit of normal value, aspartate aminotransferase (AST)> 3 times the upper limit of normal value, total bilirubin (TBIL)> upper limit of normal value 2 Times, serum creatinine clearance rate <30ml/min;
Other serious medical conditions will affect the study (such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc.). The decision-making power belongs to the researcher;
Trial design
Design model
Single group
Treatments tested in this trial
Zanubrutinib, Bendamustine and Rituximab
DrugZanubrutinib, 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.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Zanubrutinib, bendamustine, rituximab combination therapy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
Overall survival(OS)
3-year OS rate after treatment
Time frame
Up to 3 years after the end of treatment4
Progression free survival(PFS)
3-year PFS rate after treatment
Time frame
Up to 3 years after the end of treatmentSponsors and contacts
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Source ClinicalTrials.gov