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NCT03336333 · OUTCOME

Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL · Source last updated 2026-03-09

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 approximately 3 years and 7 months (as of cut-off date of 07MAY2021)

What was measured

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).

Analysis population: ITT analysis set included all enrolled participants who were assigned to a treatment group

Groups in this outcome

Cohort 1: Bendamustine + Rituximab Without Del(17p)

Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)

Cohort 1: Zanubrutinib Without Del(17p)

Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day until unacceptable toxicity or disease progression

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Bendamustine + Rituximab Without Del(17p)238
Cohort 1: Zanubrutinib Without Del(17p)241

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Bendamustine + Rituximab Without Del(17p)33.7Not reported28.1NANot estimable due to low number of PFS events
Cohort 1: Zanubrutinib Without Del(17p)NANot reportedNANANot estimable due to low number of PFS events

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.63
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    One-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.42
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.63
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    One-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.42
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to low number of PFS events
        group Id
        OG000
        lower Limit
        28.1
        upper Limit
        NA
        value
        33.7
      2. comment
        Not estimable due to low number of PFS events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      241
    units
    Participants
description
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).
dispersion Type
95% Confidence Interval
groups
  1. description
    Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)
    id
    OG000
    title
    Cohort 1: Bendamustine + Rituximab Without Del(17p)
  2. description
    Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day until unacceptable toxicity or disease progression
    id
    OG001
    title
    Cohort 1: Zanubrutinib Without Del(17p)
param Type
MEDIAN
population Description
ITT analysis set included all enrolled participants who were assigned to a treatment group
reporting Status
POSTED
time Frame
Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)
title
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice