NCT00471497 · OUTCOME
Rate of MMR at 6 Months and Beyond in All 3 Treatment Arms
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
- 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months
What was measured
MMR is defined as the percentage of participants in MMR (reduction of ≥ 3 logs in BCR-ABL transcripts compared to the standardized baseline established in IRIS, or ≤ 0.1% BCR-ABL/ABL % by international scale and measured by real-time quantitative polymerase chain reaction (RQ-PCR)) at 6 months and beyond up to 120 months based on final data.
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
MMR at M6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 12.0 | Not reported | 8.5 | 16.4 | Not reported |
|---|
| Nilotinb 300 mg BID | 33.0 | Not reported | 27.5 | 38.8 | Not reported |
|---|
| Nilotinib 400 mg BID | 29.5 | Not reported | 24.3 | 35.2 | Not reported |
|---|
MMR at M12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 22.3 | Not reported | 17.6 | 27.6 | Not reported |
|---|
| Nilotinb 300 mg BID | 44.7 | Not reported | 38.8 | 50.7 | Not reported |
|---|
| Nilotinib 400 mg BID | 43.1 | Not reported | 37.2 | 49.1 | Not reported |
|---|
MMR at M24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 37.5 | Not reported | 31.8 | 43.4 | Not reported |
|---|
| Nilotinb 300 mg BID | 61.7 | Not reported | 55.8 | 67.4 | Not reported |
|---|
| Nilotinib 400 mg BID | 59.1 | Not reported | 53.1 | 64.9 | Not reported |
|---|
MMR at M36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 38.5 | Not reported | 32.8 | 44.5 | Not reported |
|---|
| Nilotinb 300 mg BID | 59.2 | Not reported | 53.2 | 65.0 | Not reported |
|---|
| Nilotinib 400 mg BID | 57.3 | Not reported | 51.3 | 63.2 | Not reported |
|---|
MMR at M48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 43.8 | Not reported | 38.0 | 49.8 | Not reported |
|---|
| Nilotinb 300 mg BID | 59.9 | Not reported | 54.0 | 65.7 | Not reported |
|---|
| Nilotinib 400 mg BID | 55.2 | Not reported | 49.1 | 61.1 | Not reported |
|---|
MMR at M60
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 49.1 | Not reported | 43.2 | 55.1 | Not reported |
|---|
| Nilotinb 300 mg BID | 62.8 | Not reported | 56.8 | 68.4 | Not reported |
|---|
| Nilotinib 400 mg BID | 61.2 | Not reported | 55.2 | 66.9 | Not reported |
|---|
MMR at M72
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 41.7 | Not reported | 35.9 | 47.7 | Not reported |
|---|
| Nilotinb 300 mg BID | 52.5 | Not reported | 46.5 | 58.4 | Not reported |
|---|
| Nilotinib 400 mg BID | 57.7 | Not reported | 51.6 | 63.5 | Not reported |
|---|
MMR at M84
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 40.3 | Not reported | 34.5 | 46.3 | Not reported |
|---|
| Nilotinb 300 mg BID | 50.0 | Not reported | 44.0 | 56.0 | Not reported |
|---|
| Nilotinib 400 mg BID | 50.9 | Not reported | 44.9 | 56.9 | Not reported |
|---|
MMR at M96
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 37.5 | Not reported | 31.8 | 43.4 | Not reported |
|---|
| Nilotinb 300 mg BID | 46.1 | Not reported | 40.2 | 52.1 | Not reported |
|---|
| Nilotinib 400 mg BID | 46.3 | Not reported | 40.3 | 52.3 | Not reported |
|---|
MMR at M108
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 37.5 | Not reported | 31.8 | 43.4 | Not reported |
|---|
| Nilotinb 300 mg BID | 43.3 | Not reported | 37.4 | 49.3 | Not reported |
|---|
| Nilotinib 400 mg BID | 40.2 | Not reported | 34.4 | 46.2 | Not reported |
|---|
MMR at M120
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib 400 mg QD | 36.4 | Not reported | 30.8 | 42.3 | Not reported |
|---|
| Nilotinb 300 mg BID | 37.9 | Not reported | 32.3 | 43.9 | Not reported |
|---|
| Nilotinib 400 mg BID | 39.1 | Not reported | 33.4 | 45.1 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.5
- upper Limit
- 16.4
- value
- 12.0
- group Id
- OG001
- lower Limit
- 27.5
- upper Limit
- 38.8
- value
- 33.0
- group Id
- OG002
- lower Limit
- 24.3
- upper Limit
- 35.2
- value
- 29.5
- title
- MMR at M6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.6
- upper Limit
- 27.6
- value
- 22.3
- group Id
- OG001
- lower Limit
- 38.8
- upper Limit
- 50.7
- value
- 44.7
- group Id
- OG002
- lower Limit
- 37.2
- upper Limit
- 49.1
- value
- 43.1
- title
- MMR at M12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.8
- upper Limit
- 43.4
- value
- 37.5
- group Id
- OG001
- lower Limit
- 55.8
- upper Limit
- 67.4
- value
- 61.7
- group Id
- OG002
- lower Limit
- 53.1
- upper Limit
- 64.9
- value
- 59.1
- title
- MMR at M24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.8
- upper Limit
- 44.5
- value
- 38.5
- group Id
- OG001
- lower Limit
- 53.2
- upper Limit
- 65.0
- value
- 59.2
- group Id
- OG002
- lower Limit
- 51.3
- upper Limit
- 63.2
- value
- 57.3
- title
- MMR at M36
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.0
- upper Limit
- 49.8
- value
- 43.8
- group Id
- OG001
- lower Limit
- 54.0
- upper Limit
- 65.7
- value
- 59.9
- group Id
- OG002
- lower Limit
- 49.1
- upper Limit
- 61.1
- value
- 55.2
- title
- MMR at M48
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.2
- upper Limit
- 55.1
- value
- 49.1
- group Id
- OG001
- lower Limit
- 56.8
- upper Limit
- 68.4
- value
- 62.8
- group Id
- OG002
- lower Limit
- 55.2
- upper Limit
- 66.9
- value
- 61.2
- title
- MMR at M60
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.9
- upper Limit
- 47.7
- value
- 41.7
- group Id
- OG001
- lower Limit
- 46.5
- upper Limit
- 58.4
- value
- 52.5
- group Id
- OG002
- lower Limit
- 51.6
- upper Limit
- 63.5
- value
- 57.7
- title
- MMR at M72
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.5
- upper Limit
- 46.3
- value
- 40.3
- group Id
- OG001
- lower Limit
- 44.0
- upper Limit
- 56.0
- value
- 50.0
- group Id
- OG002
- lower Limit
- 44.9
- upper Limit
- 56.9
- value
- 50.9
- title
- MMR at M84
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.8
- upper Limit
- 43.4
- value
- 37.5
- group Id
- OG001
- lower Limit
- 40.2
- upper Limit
- 52.1
- value
- 46.1
- group Id
- OG002
- lower Limit
- 40.3
- upper Limit
- 52.3
- value
- 46.3
- title
- MMR at M96
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.8
- upper Limit
- 43.4
- value
- 37.5
- group Id
- OG001
- lower Limit
- 37.4
- upper Limit
- 49.3
- value
- 43.3
- group Id
- OG002
- lower Limit
- 34.4
- upper Limit
- 46.2
- value
- 40.2
- title
- MMR at M108
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.8
- upper Limit
- 42.3
- value
- 36.4
- group Id
- OG001
- lower Limit
- 32.3
- upper Limit
- 43.9
- value
- 37.9
- group Id
- OG002
- lower Limit
- 33.4
- upper Limit
- 45.1
- value
- 39.1
- title
- MMR at M120
- denoms
- counts
- group Id
- OG000
- value
- 283
- group Id
- OG001
- value
- 282
- group Id
- OG002
- value
- 281
- units
- Participants
- description
- MMR is defined as the percentage of participants in MMR (reduction of ≥ 3 logs in BCR-ABL transcripts compared to the standardized baseline established in IRIS, or ≤ 0.1% BCR-ABL/ABL % by international scale and measured by real-time quantitative polymerase chain reaction (RQ-PCR)) at 6 months and beyond up to 120 months based on final data.
- 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
- 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months
- title
- Rate of MMR at 6 Months and Beyond in All 3 Treatment Arms
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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