NCT02604511 · OUTCOME

Major Response Rate

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 4 years

What was measured

To asses the percentage of participants with a Partial Response (PR) (50% reduction or more in serum IgM) or better.

Analysis population: All participants except one participant 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 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. Ibrutinib

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

Analysis denominator · Participants

Group	Source count
Ibrutinib	30

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib	26	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
26

denoms

counts
group Id
OG000
value
30
units
Participants

description

To asses the percentage of participants with a Partial Response (PR) (50% reduction or more in serum IgM) or better.

groups

description
This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated 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. Ibrutinib
id
OG000
title
Ibrutinib

param Type

COUNT_OF_PARTICIPANTS

population Description

All participants except one participant determined to be ineligible

reporting Status

POSTED

time Frame

4 years

title

Major Response Rate

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice