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NCT02141282 · OUTCOME

Percentage of Participants With Minimal Residual Disease (MRD) Negativity Status

A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy · Source last updated 2022-12-19

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
Assessed at Week 24, Day 1; after the first Complete Response, Complete Remission with Incomplete Marrow Recovery, or Partial Response; at 12-week interval visits until two consecutive negative MRD levels were reported

What was measured

The rate of MRD response is defined as the percentage of participants who had MRD negative status.

Analysis population: All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax; indeterminate or missing samples were considered MRD positive for the calculation

Groups in this outcome

ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts

Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts

ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts

Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts

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

Analysis denominator · Participants

GroupSource count
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts91
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts36

Reported measurements

Peripheral blood
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts30.8Not reported21.541.3Not reported
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts25.0Not reported12.142.2Not reported
Bone marrow
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts6.6Not reported2.513.8Not reported
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts11.1Not reported3.126.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.5
        upper Limit
        41.3
        value
        30.8
      2. group Id
        OG001
        lower Limit
        12.1
        upper Limit
        42.2
        value
        25.0
    title
    Peripheral blood
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        13.8
        value
        6.6
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        26.1
        value
        11.1
    title
    Bone marrow
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      36
    units
    Participants
description
The rate of MRD response is defined as the percentage of participants who had MRD negative status.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
    id
    OG000
    title
    ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
  2. description
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
    id
    OG001
    title
    ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
param Type
NUMBER
population Description
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax; indeterminate or missing samples were considered MRD positive for the calculation
reporting Status
POSTED
time Frame
Assessed at Week 24, Day 1; after the first Complete Response, Complete Remission with Incomplete Marrow Recovery, or Partial Response; at 12-week interval visits until two consecutive negative MRD levels were reported
title
Percentage of Participants With Minimal Residual Disease (MRD) Negativity Status
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice