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NCT02604511 · OUTCOME

Duration of Response

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing · Source last updated 2022-12-07

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
6 years

What was measured

The amount of time between attainment of at least a minor response and disease progression.

Analysis population: All participants except one determined to be ineligible

Groups in this outcome

Ibrutinib

This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated Waldenstrom's macroglobulinemia (WM) patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.

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

Analysis denominator · Participants

GroupSource count
Ibrutinib30

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ibrutinib46Not reported155Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        55
        value
        46
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
The amount of time between attainment of at least a minor response and disease progression.
dispersion Type
Full Range
groups
  1. description
    This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated Waldenstrom's macroglobulinemia (WM) patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.
    id
    OG000
    title
    Ibrutinib
param Type
MEDIAN
population Description
All participants except one determined to be ineligible
reporting Status
POSTED
time Frame
6 years
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice