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NCT01010061 · OUTCOME

Percentage of Participants With Best Overall Response

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)

What was measured

Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \>1.5 x 10\^9/L, Platelets \>100 x 10\^9/L, Hemoglobin \>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \>1.5 x 10\^9/ or ≥50% increase, Platelets \>100 x 10\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.

Analysis population: Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.

Groups in this outcome

Obinutuzumab + Chlorambucil (GClb)

Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

Chlorambucil (Clb)

Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab + Chlorambucil (GClb)238
Chlorambucil (Clb)118

Reported measurements

Complete Response (CR)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)26.5Not reported21.032.6Not reported
Chlorambucil (Clb)0.0Not reported03.1Not reported
Complete Response incomplete (CRi)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)2.5Not reported0.95.4Not reported
Chlorambucil (Clb)1.7Not reported0.26Not reported
Partial Response (PR)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)47.1Not reported40.653.6Not reported
Chlorambucil (Clb)31.4Not reported23.140.5Not reported
Nodular Partial Response (nPR)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)2.1Not reported0.74.8Not reported
Chlorambucil (Clb)0Not reported03.1Not reported
Stable Disease
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)4.2Not reported27.6Not reported
Chlorambucil (Clb)21.2Not reported14.229.7Not reported
Progressive Disease
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)4.2Not reported2.07.6Not reported
Chlorambucil (Clb)28.8Not reported20.837.9Not reported
No Response Assessment
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)13.4Not reportedNANA95% CI was not estimated.
Chlorambucil (Clb)16.9Not reportedNANA95% CI was not estimated.

Source statistical analyses

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

  1. ci Lower Limit
    34.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    55.5
    group Description
    Includes subjects with best overall response: CR, CRi, PR or nPR.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    param Type
    Difference in Response Rates
    param Value
    45.1
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    34.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    55.5
    group Description
    Includes subjects with best overall response: CR, CRi, PR or nPR.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    param Type
    Difference in Response Rates
    param Value
    45.1
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.0
        upper Limit
        32.6
        value
        26.5
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        3.1
        value
        0.0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        5.4
        value
        2.5
      2. group Id
        OG001
        lower Limit
        0.2
        upper Limit
        6
        value
        1.7
    title
    Complete Response incomplete (CRi)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.6
        upper Limit
        53.6
        value
        47.1
      2. group Id
        OG001
        lower Limit
        23.1
        upper Limit
        40.5
        value
        31.4
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        4.8
        value
        2.1
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        3.1
        value
        0
    title
    Nodular Partial Response (nPR)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        7.6
        value
        4.2
      2. group Id
        OG001
        lower Limit
        14.2
        upper Limit
        29.7
        value
        21.2
    title
    Stable Disease
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        7.6
        value
        4.2
      2. group Id
        OG001
        lower Limit
        20.8
        upper Limit
        37.9
        value
        28.8
    title
    Progressive Disease
  7. categories
    1. measurements
      1. comment
        95% CI was not estimated.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        13.4
      2. comment
        95% CI was not estimated.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        16.9
    title
    No Response Assessment
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      118
    units
    Participants
description
Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \>1.5 x 10\^9/L, Platelets \>100 x 10\^9/L, Hemoglobin \>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \>1.5 x 10\^9/ or ≥50% increase, Platelets \>100 x 10\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    OG000
    title
    Obinutuzumab + Chlorambucil (GClb)
  2. description
    Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
    id
    OG001
    title
    Chlorambucil (Clb)
param Type
NUMBER
population Description
Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.
reporting Status
POSTED
time Frame
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
title
Percentage of Participants With Best Overall Response
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice