NCT00471497 · OUTCOME

Rate of Hematologic Response

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) · Source last updated 2020-11-18

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: 12 months, 24 months, Overall on Core study (approx. 11 years)

What was measured

Rate of hematologic response is defined as the percentage of participants in complete hematologic response (defined as the following present for at least 4 weeks: WBC count \<10 x 109/L, Platelet count \<450 x 109/L, Basophils \<5%, No blasts and promyelocytes in peripheral blood, Myelocytes + metamyelocytes \< 5% in peripheral blood, No evidence of extramedullary disease, including spleen and liver).

Analysis population: Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received

Groups in this outcome

Imatinib 400 mg QD

Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated

Nilotinb 300 mg BID

Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.

Nilotinib 400 mg BID

Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.

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
Imatinib 400 mg QD	283
Nilotinb 300 mg BID	282
Nilotinib 400 mg BID	281

Reported measurements

Complete hematologic response (CHR) by M12

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Imatinib 400 mg QD	93.3	Not reported	89.7	95.9	Not reported
Nilotinb 300 mg BID	90.1	Not reported	86.0	93.3	Not reported
Nilotinib 400 mg BID	89.0	Not reported	84.7	92.4	Not reported

CHR by M24

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Imatinib 400 mg QD	93.6	Not reported	90.1	96.2	Not reported
Nilotinb 300 mg BID	90.8	Not reported	86.8	93.9	Not reported
Nilotinib 400 mg BID	90.4	Not reported	86.3	93.6	Not reported

CHR Overall

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Imatinib 400 mg QD	94.0	Not reported	90.6	96.5	Not reported
Nilotinb 300 mg BID	92.2	Not reported	88.4	95.0	Not reported
Nilotinib 400 mg BID	90.7	Not reported	86.7	93.9	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
89.7
upper Limit
95.9
value
93.3
group Id
OG001
lower Limit
86.0
upper Limit
93.3
value
90.1
group Id
OG002
lower Limit
84.7
upper Limit
92.4
value
89.0
title
Complete hematologic response (CHR) by M12
categories
measurements
group Id
OG000
lower Limit
90.1
upper Limit
96.2
value
93.6
group Id
OG001
lower Limit
86.8
upper Limit
93.9
value
90.8
group Id
OG002
lower Limit
86.3
upper Limit
93.6
value
90.4
title
CHR by M24
categories
measurements
group Id
OG000
lower Limit
90.6
upper Limit
96.5
value
94.0
group Id
OG001
lower Limit
88.4
upper Limit
95.0
value
92.2
group Id
OG002
lower Limit
86.7
upper Limit
93.9
value
90.7
title
CHR Overall

denoms

counts
group Id
OG000
value
283
group Id
OG001
value
282
group Id
OG002
value
281
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
id
OG000
title
Imatinib 400 mg QD
description
Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
id
OG001
title
Nilotinb 300 mg BID
description
Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
id
OG002
title
Nilotinib 400 mg BID

param Type

NUMBER

population Description

Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received

reporting Status

POSTED

time Frame

12 months, 24 months, Overall on Core study (approx. 11 years)

title

Rate of Hematologic Response

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice