Trials / Completed

CompletedNCT04062448

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

Phase 2 Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Combination With Rituximab, in Japanese Patients With Waldenstrom's Macroglobulinemia (WM)

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 16 (actual)

Sponsor: Janssen Pharmaceutical K.K. · Industry
Sex: All
Age: 20 Years
Healthy volunteers: Not accepted

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).

Conditions

Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib 420 mg will be administered orally.
DRUG	Rituximab	Rituximab 375 mg/m\^2 will be administered intravenously.

Timeline

Start date: 2019-09-25
Primary completion: 2021-08-24
Completion: 2023-03-02
First posted: 2019-08-20
Last updated: 2025-05-25
Results posted: 2022-12-01

Locations

9 sites across 1 country: Japan

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04062448. Inclusion in this directory is not an endorsement.