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NCT02141282 · OUTCOME

Time to Next Anti-Chronic Lymphocytic Leukemia Treatment (TNNT)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Collected every 3 months for a period of 5 years after the last participant had enrolled into the study

What was measured

TNNT is defined as the number of days from the date of the first dose of venetoclax to the date of first dose of any non-protocol anti-leukemia therapy (NPT) or death from any cause. For participants who did not take NPT, their data was censored at the last known date to be free of NPT. TTNT was analyzed by Kaplan-Meier methodology.

Analysis population: All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax

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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts24.0Not reported18.740.9Not reported
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts37.8Not reported17.1NANot calculable/estimable due to low number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.7
        upper Limit
        40.9
        value
        24.0
      2. comment
        Not calculable/estimable due to low number of participants with events
        group Id
        OG001
        lower Limit
        17.1
        upper Limit
        NA
        value
        37.8
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      36
    units
    Participants
description
TNNT is defined as the number of days from the date of the first dose of venetoclax to the date of first dose of any non-protocol anti-leukemia therapy (NPT) or death from any cause. For participants who did not take NPT, their data was censored at the last known date to be free of NPT. TTNT was analyzed by Kaplan-Meier methodology.
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
MEDIAN
population Description
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax
reporting Status
POSTED
time Frame
Collected every 3 months for a period of 5 years after the last participant had enrolled into the study
title
Time to Next Anti-Chronic Lymphocytic Leukemia Treatment (TNNT)
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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

Preserved source evidence · Not medical advice