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NCT02343120 · OUTCOME

Part 1 and Part 2: Duration of Response (DOR)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 years and 7 months

What was measured

DOR for responders is defined as time from the date of the earliest qualifying response to the date of progressive disease or death for any cause, whichever occurs earlier. Efficacy results are reported for responders (defined as PR or better, except CLL/SLL and WM) in each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; PR with lymphocytosis or better), Waldenstrom macroglobulinemia (WM; minor response or better), 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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall58.6Not reported52.6NAData not estimable due to insufficient number of participants with events
WM

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall73
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reported31.34NAData not estimable due to insufficient number of participants with events
MCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall57
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall28.2Not reported16.2NAData not estimable due to insufficient number of participants with events
MZL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall20
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reported6.5NAData not estimable due to insufficient number of participants with events
FL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall33
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reported8.3NAData not estimable due to insufficient number of participants with events
DLBCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall45
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall14.2Not reported2.826.2Not reported
RT

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall13
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall25.9Not reported5.9NAData not estimable due to insufficient number of participants with events
HCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall12
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reportedNANAData not estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        52.6
        upper Limit
        NA
        value
        58.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      units
      Participants
    title
    CLL/SLL
  2. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        31.34
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    WM
  3. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        16.2
        upper Limit
        NA
        value
        28.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    MCL
  4. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        6.5
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    MZL
  5. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        8.3
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    FL
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        26.2
        value
        14.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    DLBCL
  7. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        5.9
        upper Limit
        NA
        value
        25.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    RT
  8. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    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
DOR for responders is defined as time from the date of the earliest qualifying response to the date of progressive disease or death for any cause, whichever occurs earlier. Efficacy results are reported for responders (defined as PR or better, except CLL/SLL and WM) in each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; PR with lymphocytosis or better), Waldenstrom macroglobulinemia (WM; minor response or better), 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
MEDIAN
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: Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice