drugset
drugset / Trial / NCT04062448

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)

NCT04062448 ↗

Phase 2 Completed 16 enrolled Janssen Pharmaceutical K.K.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).

Timeline

Start
2019-09-25
Primary completion
2021-08-24
Completion
2023-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications

Waldenstrom macroglobulinemia