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NCT00549848 · OUTCOME

Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
End of remission induction; day 42 in Total XVI and day 46 in Total XV

What was measured

To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol.

Analysis population: We will compare the proportion of patients with Day-15 MRD≥5% on TOTXVI who are Day-42 MRD positive with the proportion of Day-46 MRD positives in the corresponding subgroup in TOTXV by Fisher's exact test.

Groups in this outcome

TOTXVI PEG 3500

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

TOTXVI PEG 2500

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

TOTXVI Not Randomized

Patients who came off study prior to randomization

All Eligible Patients in TOTXV

Day 15 MRD \> or equal to 5% in Total XV

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

Analysis denominator · Participants

GroupSource count
TOTXVI PEG 350022
TOTXVI PEG 250026
TOTXVI Not Randomized30
All Eligible Patients in TOTXV54

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TOTXVI PEG 35007Not reportedNot reportedNot reportedNot reported
TOTXVI PEG 250012Not reportedNot reportedNot reportedNot reported
TOTXVI Not Randomized20Not reportedNot reportedNot reportedNot reported
All Eligible Patients in TOTXV44Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        20
      4. group Id
        OG003
        value
        44
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      30
    4. group Id
      OG003
      value
      54
    units
    Participants
description
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol.
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
    TOTXVI PEG 3500
  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
    TOTXVI PEG 2500
  3. description
    Patients who came off study prior to randomization
    id
    OG002
    title
    TOTXVI Not Randomized
  4. description
    Day 15 MRD \> or equal to 5% in Total XV
    id
    OG003
    title
    All Eligible Patients in TOTXV
param Type
COUNT_OF_PARTICIPANTS
population Description
We will compare the proportion of patients with Day-15 MRD≥5% on TOTXVI who are Day-42 MRD positive with the proportion of Day-46 MRD positives in the corresponding subgroup in TOTXV by Fisher's exact test.
reporting Status
POSTED
time Frame
End of remission induction; day 42 in Total XVI and day 46 in Total XV
title
Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice