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NCT00549848 · OUTCOME

Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.

Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2022-08-23

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
3.5 years after the last enrollment up to 12.5 years

What was measured

The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2). The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (\<0.01%). Past experience indicate that few patients will fall into these unknown categories.

Analysis population: Per protocol, the comparison was between the two randomization arms.

Groups in this outcome

PEG 3500 Units/m^2

Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase

PEG 2500 Units/m^2

Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase

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

Analysis denominator · Participants

GroupSource count
PEG 3500 Units/m^2206
PEG 2500 Units/m^2208

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PEG 3500 Units/m^291.6Not reported87.795.5Not reported
PEG 2500 Units/m^290.7Not reported86.694.8Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.778
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.778
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.7
        upper Limit
        95.5
        value
        91.6
      2. group Id
        OG001
        lower Limit
        86.6
        upper Limit
        94.8
        value
        90.7
denoms
  1. counts
    1. group Id
      OG000
      value
      206
    2. group Id
      OG001
      value
      208
    units
    Participants
description
The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2). The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (\<0.01%). Past experience indicate that few patients will fall into these unknown categories.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
    id
    OG000
    title
    PEG 3500 Units/m^2
  2. description
    Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
    id
    OG001
    title
    PEG 2500 Units/m^2
param Type
NUMBER
population Description
Per protocol, the comparison was between the two randomization arms.
reporting Status
POSTED
time Frame
3.5 years after the last enrollment up to 12.5 years
title
Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice