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NCT01460160 · OUTCOME

Complete Remission 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 Partcipants
Interval / dispersion
Not reported
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

Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. \< 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.

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 Partcipants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort65.1Not reportedNot reportedNot reportedNot reported
End of Induction period Ib
Values in Percentage of Partcipants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort88.7Not reportedNot reportedNot reportedNot reported
End of Consolidation period
Values in Percentage of Partcipants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort93.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        65.1
    title
    End of Induction period Ia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        88.7
    title
    End of Induction period Ib
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        93.4
    title
    End of Consolidation period
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. \< 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
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
Complete Remission Rate
type
SECONDARY
unit Of Measure
Percentage of Partcipants

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

Preserved source evidence · Not medical advice