Trial · NCT00471497
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
NCT00471497, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP). Trials, record NCT00471497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471497
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
- NCT number
- NCT00471497
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 846 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Myelogenous Leukemia, Chronic
- Interventions
- nilotinib, imatinib
- First posted
- 2007-05-10
- Last updated
- 2020-11-18
- Other registries' IDs
- eudract:2007-000208-34
- Results first posted
- 2013-06-17
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation | Baseline, 12 months | 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 12 months. |
| Primary | Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | 12 months | 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 12 months. |
| Secondary | Rates of Durable MMR at 24 Months Between All 3 Arms | 24 months | Durable MMR at 24 months is defined as having MMR both at 12 months and at 24 months, and with no documented loss of MMR between these 12 month and 24 month time points. |
| Secondary | Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months and Beyond 12 Months | 12, 24, 36, 48, 60, 72 months (M) | CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics. Patients with no CCyR as the best response by any specific time point, all missing cytogenetic evaluations by that time point or Ph- at baseline are combined as "Nocomplete cytogenetic response". |
| Secondary | Rate of Major Molecular Response (MMR) at 12 Months Between Two Nilotinib Arms | 12 months | 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 12 months based on 12-month cut-off interim data. |
| Secondary | Rate of MMR at 6 Months and Beyond in All 3 Treatment Arms | 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months | 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. |
| Secondary | Rate of a ≥ 4 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib | at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months | 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) |
| Secondary | Rate of a ≥ 4.5 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib | at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months | This is the molecular response of \<=0.0032% is defined as BCR-ABL ratio (%) on IS \<= 0.0032% (corresponds to \>=4.5 log reduction of BCR-ABL transcripts from standardized baseline value) |
| Secondary | Time to First MMR | up to 84 months | Time to MMR is defined as time from date of randomization to the date of the first documented MMR in nilotinib treatment arms, compared to imatinib in adult patients with Ph+ CML in CP. |
| Secondary | Duration of MMR | approx. 11 years | Duration of MMR for patients with MMR is defined as the time between date of MMR and the earliest of the following: loss of MMR, CML-related death or progression to AP/BC during study treatment The time will be censored at last molecular assessment (PCR) date for patients for whom none of the above events is reported. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation | Baseline, 12 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | 12 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Rates of Durable MMR at 24 Months Between All 3 Arms | 24 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months and Beyond 12 Months | 12, 24, 36, 48, 60, 72 months (M) | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Rate of Major Molecular Response (MMR) at 12 Months Between Two Nilotinib Arms | 12 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Rate of MMR at 6 Months and Beyond in All 3 Treatment Arms | 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Rate of a ≥ 4 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib | at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Rate of a ≥ 4.5 Log Reduction in BCR-ABL Transcripts in Nilotinib Treatment Arms With Imatinib | at 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Time to First MMR | up to 84 months | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Months | MEDIAN |
| SECONDARY | Duration of MMR | approx. 11 years | Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received. | Months | MEDIAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group214
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation | Imatinib 400 mg QD | 22.3 | 95% Confidence Interval 17.6 to 27.6 | Percentage of participants | |
| Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation | Nilotinb 300 mg BID | 44.3 | 95% Confidence Interval 38.4 to 50.3 | Percentage of participants | |
| Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation | Nilotinib 400 mg BID | 42.7 | 95% Confidence Interval 36.8 to 48.7 | Percentage of participants | |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Imatinib 400 mg QD | Sokal risk group = Low | 26.0 | 95% Confidence Interval 17.9 to 35.5 | Percentage of participants |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Nilotinb 300 mg BID | Sokal risk group = Low | 40.8 | 95% Confidence Interval 31.2 to 50.9 | Percentage of participants |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Nilotinib 400 mg BID | Sokal risk group = Low | 53.4 | 95% Confidence Interval 43.3 to 63.3 | Percentage of participants |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Imatinib 400 mg QD | Sokal risk group = Interm. | 22.8 | 95% Confidence Interval 15.0 to 32.2 | Percentage of participants |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Nilotinb 300 mg BID | Sokal risk group = Interm. | 50.5 | 95% Confidence Interval 40.4 to 60.6 | Percentage of participants |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Nilotinib 400 mg BID | Sokal risk group = Interm. | 40.0 | 95% Confidence Interval 30.3 to 50.3 | Percentage of participants |
| Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation | Imatinib 400 mg QD | Sokal risk group = High | 16.7 | 95% Confidence Interval 9.2 to 26.8 | Percentage of participants |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Treatment Phase | STARTED | Imatinib 400 mg QD | 283 | |
| Core Treatment Phase | STARTED | Nilotinb 300 mg BID | 282 | |
| Core Treatment Phase | STARTED | Nilotinib 400 mg BID | 281 | |
| Core Treatment Phase | Safety Analysis Set | Imatinib 400 mg QD | 280 | |
| Core Treatment Phase | Safety Analysis Set | Nilotinb 300 mg BID | 279 | |
| Core Treatment Phase | Safety Analysis Set | Nilotinib 400 mg BID | 277 | |
| Core Treatment Phase | Discon. Core/Did Not Enter Ext. | Imatinib 400 mg QD | 235 | |
| Core Treatment Phase | Discon. Core/Did Not Enter Ext. | Nilotinb 300 mg BID | 256 | |
| Core Treatment Phase | Discon. Core/Did Not Enter Ext. | Nilotinib 400 mg BID | 278 | |
| Core Treatment Phase | Discontinued Core/Entered Ext. | Imatinib 400 mg QD | 48 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events2,148
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Imatinib 400 mg QD | 71 | 280 | |
| other | Anaemia | Blood and lymphatic system disorders | Nilotinib 300 mg BID | 38 | 279 | |
| other | Anaemia | Blood and lymphatic system disorders | Nilotinib 400 mg BID | 45 | 277 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 154 | 836 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib 400 mg QD | 47 | 280 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nilotinib 300 mg BID | 23 | 279 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nilotinib 400 mg BID | 22 | 277 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Patients | 92 | 836 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib 400 mg QD | 59 | 280 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nilotinib 300 mg BID | 45 | 279 |
1 to 10 of 2,148Source ClinicalTrials.gov
See all 2,148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib 400 mg QD | 4 | 280 |
| Total, all-cause mortality | Nilotinib 300 mg BID | 10 | 279 |
| Total, all-cause mortality | Nilotinib 400 mg BID | 5 | 277 |
| Total, all-cause mortality | All Patients | 19 | 836 |
| Total, other adverse events | Imatinib 400 mg QD | 275 | 280 |
| Total, other adverse events | Nilotinib 300 mg BID | 276 | 279 |
| Total, other adverse events | Nilotinib 400 mg BID | 272 | 277 |
| Total, other adverse events | All Patients | 823 | 836 |
| Total, serious adverse events | Imatinib 400 mg QD | 96 | 280 |
| Total, serious adverse events | Nilotinib 300 mg BID | 112 | 279 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00471497
GET https://conductscience.org/api/trials/v1/NCT00471497/registered?page=2