NCT00471497 · OUTCOME
Rate of a ≥ 4 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib
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
- at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months
What was measured
Molecular response of \<=0.01% is defined as BCR-ABL ratio (%) on IS \<= 0.01% (corresponds to \>=4 log reduction of BCR-ABL transcripts from standardized baseline value)
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
Molecular response of <=0.01% at 6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 1.1 | Not reported | 0.2 | 3.1 | Not reported |
|---|
| Nilotinb 300 mg BID | 8.9 | Not reported | 5.8 | 12.8 | Not reported |
|---|
| Nilotinib 400 mg BID | 5.7 | Not reported | 3.3 | 9.1 | Not reported |
|---|
Molecular response of <=0.01% at 12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 3.9 | Not reported | 2.0 | 6.8 | Not reported |
|---|
| Nilotinb 300 mg BID | 12.1 | Not reported | 8.5 | 16.4 | Not reported |
|---|
| Nilotinib 400 mg BID | 8.9 | Not reported | 5.8 | 12.9 | Not reported |
|---|
Molecular response of <=0.01% at 24 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 10.2 | Not reported | 7.0 | 14.4 | Not reported |
|---|
| Nilotinb 300 mg BID | 24.5 | Not reported | 19.6 | 29.9 | Not reported |
|---|
| Nilotinib 400 mg BID | 22.1 | Not reported | 17.4 | 27.4 | Not reported |
|---|
Molecular response of <=0.01% at 36 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 14.1 | Not reported | 10.3 | 18.7 | Not reported |
|---|
| Nilotinb 300 mg BID | 29.4 | Not reported | 24.2 | 35.1 | Not reported |
|---|
| Nilotinib 400 mg BID | 23.8 | Not reported | 19.0 | 29.3 | Not reported |
|---|
Molecular response of <=0.01% at 48 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 19.8 | Not reported | 15.3 | 24.9 | Not reported |
|---|
| Nilotinb 300 mg BID | 33.0 | Not reported | 27.5 | 38.8 | Not reported |
|---|
| Nilotinib 400 mg BID | 29.9 | Not reported | 24.6 | 35.6 | Not reported |
|---|
Molecular response of <=0.01% at 60 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 31.1 | Not reported | 25.7 | 36.8 | Not reported |
|---|
| Nilotinb 300 mg BID | 47.9 | Not reported | 41.9 | 53.9 | Not reported |
|---|
| Nilotinib 400 mg BID | 43.4 | Not reported | 37.5 | 49.4 | Not reported |
|---|
Molecular response of <=0.01% at 72 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 27.2 | Not reported | 22.1 | 32.8 | Not reported |
|---|
| Nilotinb 300 mg BID | 44.3 | Not reported | 38.4 | 50.3 | Not reported |
|---|
| Nilotinib 400 mg BID | 45.2 | Not reported | 39.3 | 51.2 | Not reported |
|---|
Molecular response of <=0.01% at 84 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 29.0 | Not reported | 23.8 | 34.6 | Not reported |
|---|
| Nilotinb 300 mg BID | 42.9 | Not reported | 37.1 | 48.9 | Not reported |
|---|
| Nilotinib 400 mg BID | 40.6 | Not reported | 34.8 | 46.6 | Not reported |
|---|
Molecular response of <=0.01% at 96 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 28.3 | Not reported | 23.1 | 33.9 | Not reported |
|---|
| Nilotinb 300 mg BID | 39.7 | Not reported | 34.0 | 45.7 | Not reported |
|---|
| Nilotinib 400 mg BID | 38.1 | Not reported | 32.4 | 44.0 | Not reported |
|---|
Molecular response of <=0.01% at 108 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 32.2 | Not reported | 26.7 | 37.9 | Not reported |
|---|
| Nilotinb 300 mg BID | 40.4 | Not reported | 34.6 | 46.4 | Not reported |
|---|
| Nilotinib 400 mg BID | 34.9 | Not reported | 29.3 | 40.8 | Not reported |
|---|
Molecular response of <=0.01% at 120 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 28.3 | Not reported | 23.1 | 33.9 | Not reported |
|---|
| Nilotinb 300 mg BID | 35.5 | Not reported | 29.9 | 41.4 | Not reported |
|---|
| Nilotinib 400 mg BID | 33.8 | Not reported | 28.3 | 39.7 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 3.1
- value
- 1.1
- group Id
- OG001
- lower Limit
- 5.8
- upper Limit
- 12.8
- value
- 8.9
- group Id
- OG002
- lower Limit
- 3.3
- upper Limit
- 9.1
- value
- 5.7
- title
- Molecular response of <=0.01% at 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 6.8
- value
- 3.9
- group Id
- OG001
- lower Limit
- 8.5
- upper Limit
- 16.4
- value
- 12.1
- group Id
- OG002
- lower Limit
- 5.8
- upper Limit
- 12.9
- value
- 8.9
- title
- Molecular response of <=0.01% at 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- 14.4
- value
- 10.2
- group Id
- OG001
- lower Limit
- 19.6
- upper Limit
- 29.9
- value
- 24.5
- group Id
- OG002
- lower Limit
- 17.4
- upper Limit
- 27.4
- value
- 22.1
- title
- Molecular response of <=0.01% at 24 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 18.7
- value
- 14.1
- group Id
- OG001
- lower Limit
- 24.2
- upper Limit
- 35.1
- value
- 29.4
- group Id
- OG002
- lower Limit
- 19.0
- upper Limit
- 29.3
- value
- 23.8
- title
- Molecular response of <=0.01% at 36 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.3
- upper Limit
- 24.9
- value
- 19.8
- group Id
- OG001
- lower Limit
- 27.5
- upper Limit
- 38.8
- value
- 33.0
- group Id
- OG002
- lower Limit
- 24.6
- upper Limit
- 35.6
- value
- 29.9
- title
- Molecular response of <=0.01% at 48 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.7
- upper Limit
- 36.8
- value
- 31.1
- group Id
- OG001
- lower Limit
- 41.9
- upper Limit
- 53.9
- value
- 47.9
- group Id
- OG002
- lower Limit
- 37.5
- upper Limit
- 49.4
- value
- 43.4
- title
- Molecular response of <=0.01% at 60 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- 32.8
- value
- 27.2
- group Id
- OG001
- lower Limit
- 38.4
- upper Limit
- 50.3
- value
- 44.3
- group Id
- OG002
- lower Limit
- 39.3
- upper Limit
- 51.2
- value
- 45.2
- title
- Molecular response of <=0.01% at 72 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.8
- upper Limit
- 34.6
- value
- 29.0
- group Id
- OG001
- lower Limit
- 37.1
- upper Limit
- 48.9
- value
- 42.9
- group Id
- OG002
- lower Limit
- 34.8
- upper Limit
- 46.6
- value
- 40.6
- title
- Molecular response of <=0.01% at 84 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.1
- upper Limit
- 33.9
- value
- 28.3
- group Id
- OG001
- lower Limit
- 34.0
- upper Limit
- 45.7
- value
- 39.7
- group Id
- OG002
- lower Limit
- 32.4
- upper Limit
- 44.0
- value
- 38.1
- title
- Molecular response of <=0.01% at 96 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.7
- upper Limit
- 37.9
- value
- 32.2
- group Id
- OG001
- lower Limit
- 34.6
- upper Limit
- 46.4
- value
- 40.4
- group Id
- OG002
- lower Limit
- 29.3
- upper Limit
- 40.8
- value
- 34.9
- title
- Molecular response of <=0.01% at 108 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.1
- upper Limit
- 33.9
- value
- 28.3
- group Id
- OG001
- lower Limit
- 29.9
- upper Limit
- 41.4
- value
- 35.5
- group Id
- OG002
- lower Limit
- 28.3
- upper Limit
- 39.7
- value
- 33.8
- title
- Molecular response of <=0.01% at 120 months
- denoms
- counts
- group Id
- OG000
- value
- 283
- group Id
- OG001
- value
- 282
- group Id
- OG002
- value
- 281
- units
- Participants
- description
- Molecular response of \<=0.01% is defined as BCR-ABL ratio (%) on IS \<= 0.01% (corresponds to \>=4 log reduction of BCR-ABL transcripts from standardized baseline value)
- 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
- at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months
- title
- Rate of a ≥ 4 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice
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