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NCT01784068 · OUTCOME

Number of Participants With BCR-ABL1 Mutations Associated With Resistance to Nilotinib After Loss of Major Molecular Response

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients · Source last updated 2026-08-13

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
From loss of major molecular response after nilotinib suspension through up to 528 weeks of study participation

What was measured

This outcome measure was the number of participants who developed BCR-ABL1 mutations associated with resistance to nilotinib following loss of major molecular response (MMR) after suspension of nilotinib treatment. Mutations assessed included, but were not limited to, T315I, E255K, Y253H, F359V, F359C, and F359I. The endpoint was calculated as the number of participants with at least one detected BCR-ABL1 mutation divided by the number of participants who experienced loss of MMR after nilotinib suspension.

Analysis population: The analysis population included participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase and underwent BCR-ABL1 mutation analysis.

Groups in this outcome

TFR Phase

Participants who completed the nilotinib treatment consolidation (NTCS) phase and maintained major molecular response entered the treatment-free remission (TFR) phase. During the TFR phase, nilotinib treatment was discontinued and participants were monitored regularly for molecular response.

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

Analysis denominator · Participants

GroupSource count
TFR Phase76

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TFR Phase1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    units
    Participants
description
This outcome measure was the number of participants who developed BCR-ABL1 mutations associated with resistance to nilotinib following loss of major molecular response (MMR) after suspension of nilotinib treatment. Mutations assessed included, but were not limited to, T315I, E255K, Y253H, F359V, F359C, and F359I. The endpoint was calculated as the number of participants with at least one detected BCR-ABL1 mutation divided by the number of participants who experienced loss of MMR after nilotinib suspension.
groups
  1. description
    Participants who completed the nilotinib treatment consolidation (NTCS) phase and maintained major molecular response entered the treatment-free remission (TFR) phase. During the TFR phase, nilotinib treatment was discontinued and participants were monitored regularly for molecular response.
    id
    OG000
    title
    TFR Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population included participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase and underwent BCR-ABL1 mutation analysis.
reporting Status
POSTED
time Frame
From loss of major molecular response after nilotinib suspension through up to 528 weeks of study participation
title
Number of Participants With BCR-ABL1 Mutations Associated With Resistance to Nilotinib After Loss of Major Molecular Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice