drugset / Trial / NCT04042376

A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM)

NCT04042376

Phase 4 Completed 17 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of ibrutinib based on overall response rate (ORR) (partial response \[PR\] or better) by investigator assessment per the modified Consensus Response Criteria from the Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (NCCN 2019), in Chinese participants with relapsed or refractory waldenstrom's macroglobulinemia.

Timeline

Start
2019-12-18
Primary completion
2024-03-19
Completion
2024-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral