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NCT01460160 · OUTCOME

Percentage of Participants Negative for Minimal Residual Disease (MRD)

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
95% Confidence Interval
Time frame
From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)

What was measured

MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%

Analysis population: All treated participants

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

End of Induction period Ia
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib Cohort28.3Not reported19.9837.88Not reported
End of Induction period Ib
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib Cohort52.8Not reported42.8962.60Not reported
End of Consolidation period
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib Cohort71.7Not reported62.1280.02Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.98
        upper Limit
        37.88
        value
        28.3
    title
    End of Induction period Ia
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.89
        upper Limit
        62.60
        value
        52.8
    title
    End of Induction period Ib
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.12
        upper Limit
        80.02
        value
        71.7
    title
    End of Consolidation period
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
dispersion Type
95% 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 participants
reporting Status
POSTED
time Frame
From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
title
Percentage of Participants Negative for Minimal Residual Disease (MRD)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice