Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04062448 · OUTCOME

Number of Participants With C-X-C Chemokine Receptor Type 4 (CXCR-4) Biomarker Mutations

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM) · Source last updated 2025-05-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 of Week 1

What was measured

Number of participants with CXCR-4 biomarker mutations were reported. CXCR-4 was assessed using next generation sequencing to detect the somatic mutations in the bone marrow aspiration samples collected during the study.

Analysis population: All treated analysis set included all enrolled participants who received at least 1 dose of ibrutinib. Here, 'N' (number of participants analyzed) refers to participants evaluable for this outcome measure.

Groups in this outcome

Ibrutinib + Rituximab

Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ibrutinib + Rituximab7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ibrutinib + Rituximab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Number of participants with CXCR-4 biomarker mutations were reported. CXCR-4 was assessed using next generation sequencing to detect the somatic mutations in the bone marrow aspiration samples collected during the study.
groups
  1. description
    Treatment naive or relapsed/refractory Waldenstrom's Macroglobulinemia (WM) Japanese participants received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity along with rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 4 consecutive weeks (Day 1 of Weeks 1 to 4), followed by a second course of once-weekly rituximab for 4 consecutive weeks (from Week 17 to 20) after a 12-week interval.
    id
    OG000
    title
    Ibrutinib + Rituximab
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated analysis set included all enrolled participants who received at least 1 dose of ibrutinib. Here, 'N' (number of participants analyzed) refers to participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Day 1 of Week 1
title
Number of Participants With C-X-C Chemokine Receptor Type 4 (CXCR-4) Biomarker Mutations
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice