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

NCT05979948 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-14

No results posted yet for this study

Summary

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.

Conditions

  • Waldenström's Macroglobulinemia

Interventions

DRUG

Zanubrutinib

Zanubrutinib, 160 mg oral capsules twice daily for 12 months

DRUG

Bendamustine

Bendamustine, 70-90 mg/m2 on days 1 and 2 of each cycle for 6 cycles.

DRUG

Rituximab

Rituximab, 375 mg/m2 intravenously on day 0 of each cycle for 6 cycles

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Huadong Hospital

    collaborator OTHER

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Juan Du, Doctor · Shanghai Changzheng Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-04-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979948 on ClinicalTrials.gov