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

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04062448
Phase
PHASE2
Status
Completed

Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 420 mg will be administered orally.
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 will be administered intravenously.

Study Details

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).

Key Dates

Start date
Sep 25, 2019
Status verified
May 2025
Primary completion
Aug 24, 2021
Completion
Mar 2, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib + Rituximab
    Participants will receive ibrutinib 420 milligram (mg) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity in combination with rituximab 375 milligram per square meter (mg/m\^2) intravenously (IV) on Day 1 of Weeks 1 to 4 and Weeks 17 to 20.

Primary Outcome Measure

Overall Response Rate (ORR) According to the Modified Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) Criteria [ Time Frame: Up to 1 year 11 months ]

Related Studies