NCT01784068 · OUTCOME

Percentage of Participants With Stable Molecular Response 4.5 (MR4.5) at Multiple Time Points After First Achievement During Nilotinib Re-Initiation

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 48, 96, 144, 192, 240, 288, 336, 384, and 432 after first achievement of MR4.5 during the nilotinib re-initiation phase

What was measured

The proportion of patients who were in stable MR4.5 after achieving a response in the NTRI phase at multiple timepoints was calculated by dividing the number of participants achieving MR4.5 any time during the NTRI phase and having the same response at those timepoints after the first achievement of MR4.5, irrespective of whether there was loss of MR4.5 in between, by the number of patients who achieved MR4.5 at any time during the NTRI phase.

Analysis population: The nilotinib treatment re-initiation (NTRI) safety set included all participants who achieved who achieved MR4.5 at least once in nilotinib re-initiation phase

Groups in this outcome

NTRI Phase

Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.

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
NTRI Phase	84

Reported measurements

Stable MR4.5 for 48 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	86.9	Not reported	77.8	93.3	Not reported

Stable MR4.5 for 96 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	76.2	Not reported	65.7	84.8	Not reported

Stable MR4.5 for 144 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	71.4	Not reported	60.5	80.8	Not reported

Stable MR4.5 for 192 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	63.1	Not reported	51.9	73.4	Not reported

Stable MR4.5 for 240 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	48.8	Not reported	37.7	60.0	Not reported

Stable MR4.5 for 288 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	42.9	Not reported	32.1	54.1	Not reported

Stable MR4.5 for 336 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	39.3	Not reported	28.8	50.5	Not reported

Stable MR4.5 for 384 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	35.7	Not reported	25.6	46.9	Not reported

Stable MR4.5 for 432 weeks

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NTRI Phase	31.0	Not reported	21.3	42.0	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
77.8
upper Limit
93.3
value
86.9
title
Stable MR4.5 for 48 weeks
categories
measurements
group Id
OG000
lower Limit
65.7
upper Limit
84.8
value
76.2
title
Stable MR4.5 for 96 weeks
categories
measurements
group Id
OG000
lower Limit
60.5
upper Limit
80.8
value
71.4
title
Stable MR4.5 for 144 weeks
categories
measurements
group Id
OG000
lower Limit
51.9
upper Limit
73.4
value
63.1
title
Stable MR4.5 for 192 weeks
categories
measurements
group Id
OG000
lower Limit
37.7
upper Limit
60.0
value
48.8
title
Stable MR4.5 for 240 weeks
categories
measurements
group Id
OG000
lower Limit
32.1
upper Limit
54.1
value
42.9
title
Stable MR4.5 for 288 weeks
categories
measurements
group Id
OG000
lower Limit
28.8
upper Limit
50.5
value
39.3
title
Stable MR4.5 for 336 weeks
categories
measurements
group Id
OG000
lower Limit
25.6
upper Limit
46.9
value
35.7
title
Stable MR4.5 for 384 weeks
categories
measurements
group Id
OG000
lower Limit
21.3
upper Limit
42.0
value
31.0
title
Stable MR4.5 for 432 weeks

denoms

counts
group Id
OG000
value
84
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.
id
OG000
title
NTRI Phase

param Type

NUMBER

population Description

The nilotinib treatment re-initiation (NTRI) safety set included all participants who achieved who achieved MR4.5 at least once in nilotinib re-initiation phase

reporting Status

POSTED

time Frame

Weeks 48, 96, 144, 192, 240, 288, 336, 384, and 432 after first achievement of MR4.5 during the nilotinib re-initiation phase

title

Percentage of Participants With Stable Molecular Response 4.5 (MR4.5) at Multiple Time Points After First Achievement During Nilotinib Re-Initiation

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice