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

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT05979948
Phase
PHASE2
Status
Unknown

Conditions

  • Waldenström's Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    Zanubrutinib, 160 mg oral capsules twice daily for 12 months
  • Bendamustine — DRUG
    Bendamustine, 70-90 mg/m2 on days 1 and 2 of each cycle for 6 cycles.
  • Rituximab — DRUG
    Rituximab, 375 mg/m2 intravenously on day 0 of each cycle for 6 cycles

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Sep 2023
Primary completion
Apr 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: zanubrutinib combined with BR regimen
    Drug: zanubrutinib,160 mg oral capsules twice daily for 12 months Drug: Bendamustine,70-90 mg/m2 on days 1 and 2 of each cycle for 6 cycles. Drug: Rituximab,375 mg/m2 intravenously on day 0 of each cycle for 6 cycles.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to the end of 12 cycles of treatment(each cycle is 28 days) ]

Central Contacts