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NCT03630042 · OUTCOME

Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment

Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia · Source last updated 2024-11-07

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
24 weeks

What was measured

The primary outcome is the percentage of patients achieving at least a major response rate at 24 weeks post commencing treatment. A major response rate is defined as a greater than 50% reduction in paraprotein measurement - this is in line with international recognised response criteria for the disease under investigation. In this single arm study all patients receiving treatment were considered applicable for endpoint analysis. There is no comparison as there is only one arm.

Groups in this outcome

Pembrolizumab and Rituximab

Pembrolizumab: 200 mg IV dose given on day 1 of a three week cycle Rituximab: 375 mg/m2 IV dose given up to 8 times in the trial

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab and Rituximab17

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab and Rituximab8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
The primary outcome is the percentage of patients achieving at least a major response rate at 24 weeks post commencing treatment. A major response rate is defined as a greater than 50% reduction in paraprotein measurement - this is in line with international recognised response criteria for the disease under investigation. In this single arm study all patients receiving treatment were considered applicable for endpoint analysis. There is no comparison as there is only one arm.
groups
  1. description
    Pembrolizumab: 200 mg IV dose given on day 1 of a three week cycle Rituximab: 375 mg/m2 IV dose given up to 8 times in the trial
    id
    OG000
    title
    Pembrolizumab and Rituximab
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
24 weeks
title
Percentage of Patients Achieving at Least a Major Response Rate at 24 Weeks Post Commencing Treatment
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice