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NCT01844765 · OUTCOME

Rate of Major Molecular Response (MMR) at 6 Cycles for Ph+ CML CP Patients Resistant or Intolerant to Imatinib or Dasatinib

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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
6 cycles

What was measured

MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR at 6 cycles if the patient met the MMR criteria at the Cycle 6 Visit.

Analysis population: Full Analysis Set (FAS): All patients who received at least one dose of study medication

Groups in this outcome

Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

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

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP33

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP39.4Not reported22.957.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.9
        upper Limit
        57.9
        value
        39.4
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR at 6 cycles if the patient met the MMR criteria at the Cycle 6 Visit.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/Intolerant Ph+ CML in CP
param Type
NUMBER
population Description
Full Analysis Set (FAS): All patients who received at least one dose of study medication
reporting Status
POSTED
time Frame
6 cycles
title
Rate of Major Molecular Response (MMR) at 6 Cycles for Ph+ CML CP Patients Resistant or Intolerant to Imatinib or Dasatinib
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice