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NCT02343120 · OUTCOME

Part 1 and Part 2: Complete Response Rate (CRR)

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies · Source last updated 2022-04-28

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 6 years and 7 months

What was measured

CRR is defined as the percentage of participants who achieve a complete response, as assessed by the investigator. For CLL/SLL, CRR includes CRi or better. For WM, CRR includes very good partial response (VGPR) or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).

Analysis population: Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.

Groups in this outcome

Part 1 and Part 2: Overall

The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.

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

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall378

Reported measurements

CLL/SLL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall125
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall16.8Not reported10.724.5Not reported
WM

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall73
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall46.6Not reported34.858.6Not reported
MCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall57
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall28.1Not reported17.041.5Not reported
MZL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall20
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall20.0Not reported5.743.7Not reported
FL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall33
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall18.2Not reported7.035.5Not reported
DLBCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall45
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall24.4Not reported12.939.5Not reported
RT

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall13
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall15.4Not reported1.945.4Not reported
HCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall16.7Not reported2.148.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.7
        upper Limit
        24.5
        value
        16.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      units
      Participants
    title
    CLL/SLL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.8
        upper Limit
        58.6
        value
        46.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    WM
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.0
        upper Limit
        41.5
        value
        28.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    MCL
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        43.7
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    MZL
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        35.5
        value
        18.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    FL
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.9
        upper Limit
        39.5
        value
        24.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    DLBCL
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        45.4
        value
        15.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    RT
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        48.4
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    HCL
denoms
  1. counts
    1. group Id
      OG000
      value
      378
    units
    Participants
description
CRR is defined as the percentage of participants who achieve a complete response, as assessed by the investigator. For CLL/SLL, CRR includes CRi or better. For WM, CRR includes very good partial response (VGPR) or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
dispersion Type
95% Confidence Interval
groups
  1. description
    The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
    id
    OG000
    title
    Part 1 and Part 2: Overall
param Type
NUMBER
population Description
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
reporting Status
POSTED
time Frame
Up to 6 years and 7 months
title
Part 1 and Part 2: Complete Response Rate (CRR)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice