NCT01784068 · OUTCOME

Percentage of Participants in Molecular Response 4.5 (MR4.5) at Multiple Time Points After Start of the Treatment-Free Remission (TFR) Phase

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: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Weeks 96, 144, 192, and 264, and End of Years 6, 7, 8, 9, and 10

What was measured

This secondary outcome measure was the percentage of participants in molecular response 4.5 (MR4.5) assessed at multiple timepoints after initiation of the treatment-free remission (TFR) phase. Participants who required reinitiation of treatment at any time prior to the respective assessment were considered non-responders. MR4.5 corresponds to a BCR-ABL transcript level ≤0.0032% on the International Scale (IS).

Analysis population: The full analysis set (FAS) included all participants who completed 52 weeks of nilotinib treatment in the NTCS phase and subsequently entered the TFR phase

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

Group	Source count
TFR Phase	190

Reported measurements

Week 96 response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	46.3	Not reported	39.1	53.7	Not reported

Week 144 response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	45.8	Not reported	38.6	53.2	Not reported

Week 192 response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	43.2	Not reported	36.0	50.5	Not reported

Week 264 response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	40.0	Not reported	33.0	47.3	Not reported

Week 312 (Year 6) response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	37.9	Not reported	31.0	45.2	Not reported

Week 360 (Year 7) response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	36.3	Not reported	29.5	43.6	Not reported

Week 408 (year 8) response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	35.3	Not reported	28.5	42.5	Not reported

Week 468 (year 9) response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	33.7	Not reported	27.0	40.9	Not reported

Week 528 (year 10) response

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TFR Phase	25.3	Not reported	19.3	32.1	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
39.1
upper Limit
53.7
value
46.3
title
Week 96 response
categories
measurements
group Id
OG000
lower Limit
38.6
upper Limit
53.2
value
45.8
title
Week 144 response
categories
measurements
group Id
OG000
lower Limit
36.0
upper Limit
50.5
value
43.2
title
Week 192 response
categories
measurements
group Id
OG000
lower Limit
33.0
upper Limit
47.3
value
40.0
title
Week 264 response
categories
measurements
group Id
OG000
lower Limit
31.0
upper Limit
45.2
value
37.9
title
Week 312 (Year 6) response
categories
measurements
group Id
OG000
lower Limit
29.5
upper Limit
43.6
value
36.3
title
Week 360 (Year 7) response
categories
measurements
group Id
OG000
lower Limit
28.5
upper Limit
42.5
value
35.3
title
Week 408 (year 8) response
categories
measurements
group Id
OG000
lower Limit
27.0
upper Limit
40.9
value
33.7
title
Week 468 (year 9) response
categories
measurements
group Id
OG000
lower Limit
19.3
upper Limit
32.1
value
25.3
title
Week 528 (year 10) response

denoms

counts
group Id
OG000
value
190
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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

NUMBER

population Description

The full analysis set (FAS) included all participants who completed 52 weeks of nilotinib treatment in the NTCS phase and subsequently entered the TFR phase

reporting Status

POSTED

time Frame

Weeks 96, 144, 192, and 264, and End of Years 6, 7, 8, 9, and 10

title

Percentage of Participants in Molecular Response 4.5 (MR4.5) at Multiple Time Points After Start of the Treatment-Free Remission (TFR) Phase

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice