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NCT01460160 · OUTCOME

3-year Event-free Survival (EFS) Rate

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia · Source last updated 2021-12-08

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
90% Confidence Interval
Time frame
From first dose to 3 years following first dose

What was measured

3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause

Analysis population: All treated partcipants

Groups in this outcome

Dasatinib Cohort

Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.

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

Analysis denominator · Participants

GroupSource count
Dasatinib Cohort106

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib Cohort66.0Not reported57.773.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    3.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    29.8
    estimate Comment
    Treatment difference (CA180372 - AIEOP-BFM 2000)
    group Description
    Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.032
    p Value Comment
    Superiority test versus AIEOP-BFM 2000
    param Type
    Estimate of Difference
    param Value
    16.86
    statistical Method
    Chi-squared
  2. ci Lower Limit
    -3.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    17.2
    estimate Comment
    Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%
    group Description
    Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control
    group Ids
    1. OG000
    non Inferiority Comment
    non-inferiority margin = 5%. One-sided type I error rate of 0.05
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.271
    p Value Comment
    Superiority test versus EsPhALL
    param Type
    Estimate of difference
    param Value
    6.91
    statistical Method
    Chi-squared
  3. ci Lower Limit
    -22.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.2
    estimate Comment
    Treatment difference (CA180372 - COG AALL0031)
    group Ids
    1. OG000
    non Inferiority Comment
    Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control
    non Inferiority Type
    SUPERIORITY
    p Value
    0.157
    param Type
    Estimate of difference
    param Value
    -10.75
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    3.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    29.8
    estimate Comment
    Treatment difference (CA180372 - AIEOP-BFM 2000)
    group Description
    Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.032
    p Value Comment
    Superiority test versus AIEOP-BFM 2000
    param Type
    Estimate of Difference
    param Value
    16.86
    statistical Method
    Chi-squared
  2. ci Lower Limit
    -3.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    17.2
    estimate Comment
    Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%
    group Description
    Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control
    group Ids
    1. OG000
    non Inferiority Comment
    non-inferiority margin = 5%. One-sided type I error rate of 0.05
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.271
    p Value Comment
    Superiority test versus EsPhALL
    param Type
    Estimate of difference
    param Value
    6.91
    statistical Method
    Chi-squared
  3. ci Lower Limit
    -22.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.2
    estimate Comment
    Treatment difference (CA180372 - COG AALL0031)
    group Ids
    1. OG000
    non Inferiority Comment
    Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control
    non Inferiority Type
    SUPERIORITY
    p Value
    0.157
    param Type
    Estimate of difference
    param Value
    -10.75
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.7
        upper Limit
        73.7
        value
        66.0
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause
dispersion Type
90% Confidence Interval
groups
  1. description
    Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
    id
    OG000
    title
    Dasatinib Cohort
param Type
NUMBER
population Description
All treated partcipants
reporting Status
POSTED
time Frame
From first dose to 3 years following first dose
title
3-year Event-free Survival (EFS) Rate
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice