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NCT03506373 · OUTCOME

Overall Response Rate

Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2026-05-05

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

Overall response rate will be estimated by the total number of patients who achieve a CR, very good partial response (VGPR), or partial response (PR) divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. Response is categorized by Response Assessment Criteria as specified in Appendix III of the protocol.

Groups in this outcome

Treatment (Ixazomib Citrate, Ibrutinib)

Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. \> \> Ibrutinib: Given PO \> \> Ixazomib Citrate: Given PO \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Pharmacodynamic Study: Correlative studies \> \> Pharmacokinetic Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Ixazomib Citrate, Ibrutinib)21

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Ixazomib Citrate, Ibrutinib)76.0Not reported52.8391.78Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.83
        upper Limit
        91.78
        value
        76.0
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Overall response rate will be estimated by the total number of patients who achieve a CR, very good partial response (VGPR), or partial response (PR) divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. Response is categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. \> \> Ibrutinib: Given PO \> \> Ixazomib Citrate: Given PO \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Pharmacodynamic Study: Correlative studies \> \> Pharmacokinetic Study: Correlative studies
    id
    OG000
    title
    Treatment (Ixazomib Citrate, Ibrutinib)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 5 years
title
Overall Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice